An interventional study of Oral tobacco-derived nicotine product (OTDN) in Tobacco Use, sponsored by Altria Client Services LLC. Completed at 3 sites in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Altria Client Services LLC · Not applicable, Interventional, and Other
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Among 311 studies in Tobacco Use with a site in United States — 52 open to participants now, 63 under way, 1 of them phase 3. Tobacco Use · United States.
Among the 311 studies in Tobacco Use with a site in United States, this one is the 121st largest by enrollment of the 286 interventional ones that give a count, is one of 8 that started in 2013, is one of 231 with no phase, and was the 145th registered.
421 studies on the registry are indexed under Tobacco Use; 83 are open to participants now.
Browse Tobacco Use studies →52 of the 311 studies in Tobacco Use with a site in United States are open now. Recruiting first, the newest first:
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
University of Pennsylvania · Sites in United States
Ages 18+
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
University of Pittsburgh · Sites in United States
Ages 18+ · Women only
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 50 Tobacco Use studies recruiting now, 28 (56%) set no upper age limit and 18 (36%) stop at 75 or younger; 2 take children under 18; 27 take healthy volunteers.
This study: 21 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
311 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 22 · Phase 3 10 · Phase 4 9
First in 1992; this study’s year is marked. 8 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 154 is above the median of 127 across 352 interventional studies indexed under Tobacco Use.
Median enrollment 120 across the 286 interventional studies, 174 across the 24 observational. Of the 232 that completed or were terminated, 82 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
67 of 311 have an industry lead sponsor. The 10 most frequent:
Altria Client Services LLC is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Altria Client Services LLC has 9 studies filed under Tobacco Use — fewer than ten, so there is no comparison to draw.
30 of the studies in Tobacco Use with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05707871Wake Forest University Health SciencesCardiovascular Effects of Very Low Nicotine Content Cigarettes | 2026-12 |
| NCT07710820RAI Services CompanyA Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers | 2026-12 |
| NCT05445804Johns Hopkins UniversityOral Cannabidiol for Tobacco Cessation | 2026-12-01 |
| NCT07598136RAI Services CompanyA Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers | 2026-12-17 |
| NCT04297592Mayo ClinicAntibiotic Prophylaxis in High-Risk Arthroplasty Patients | 2027-01 |
Add all 30 to your calendar (.ics) → With an account.
Among the 311 studies in Tobacco Use with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.
This was a randomized, controlled, open-label, parallel group, multicenter, 9-week study to determine changes in BOE in adult smokers allowed ad libitum use of an OTDN product relative to adult smokers who were not allowed to use an OTDN product. This study was conducted in adult smokers who were considered to be in overall good health. Subjects were randomized to Test (allowed OTDN use) or Control (not allowed OTDN use) groups.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject must:
Exclusion Criteria:
Subject must not:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects were asked to continue smoking their own brand of cigarettes ad libitum for 4 weeks
Subjects were allowed to continue smoking their own brand of cigarettes ad libitum and provided the option to use an OTDN (specifically, VERVE® Discs Blue Mint \[VBM-FG2\]) also under ad libitum conditions
Other: Oral tobacco-derived nicotine product (OTDN)
Also known as: VERVE® Discs Blue Mint, VBM-FG2 oral discs
Summary Statistics of Percent Change From Baseline for Urinary Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) (%) (Per-Protocol Population)
Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a Statistical Analysis System (SAS®) procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Change From Baseline for Urinary Total NNAL (ng/g Creatinine) (Per-Protocol Population)
Summary statistics of change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Change From Baseline for Nicotine Equivalents (mg / g Creatinine) (Per-Protocol Population)
Summary statistics of change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (mg/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Percent Change From Baseline for Nicotine Equivalents (%) (Per-Protocol Population)
Summary statistics of percent change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Change From Baseline for S-phenyl Mercapturic Acid (S-PMA) (ng/g Creatinine) (Per-Protocol Population)
Summary statistics of change from Baseline for urinary S-phenyl mercapturic acid \[S-PMA\] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Percent Change From Baseline for S-PMA (%) (Per-Protocol Population)
Summary statistics of percent change from Baseline for urinary S-phenyl mercapturic acid \[S-PMA\] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)
Summary statistics of change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Percent Change From Baseline for Carboxyhemoglobin (%) (Per-Protocol Population)
Summary statistics of percent change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Change From Baseline for Exhaled Carbon Monoxide (Ppm) (Per-Protocol Population)
Summary statistics of change from Baseline for exhaled carbon monoxide (ppm) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Percent Change From Baseline for Exhaled Carbon Monoxide (%) (Per-Protocol Population)
Summary statistics of percent change from Baseline for exhaled carbon monoxide (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Change From Baseline in Cigarettes Smoked Per Day (Per-Protocol Population)
Summary statistics of change from Baseline in number or products used day in each study visit are presented. Values for visit are the average of daily values for the previous week Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Percent Change From Baseline for Cigarettes Smoked Per Day (CPD) (Per-Protocol Population)
Summary statistics of percent change from Baseline of number of products used per day in each study visit are presented. CPD was tracked using an interactive voice response system (IVRS). During the Baseline Period (Days 1 to 8), subjects reported CPD daily through an IVRS each day between 16:00 and 19:00. Test and Control subjects continued daily tobacco use tracking via an IVRS and return to the study site once a week during the 4 week Product Use Period on Days 15, 22, 29, and 36. Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing the calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS procedure.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Change From Baseline for Total Score of Fagerstrom Test for Cigarette Dependence (Per-Protocol Population)
Summary statistics of change from Baseline for Total Score of Fagerstrom Test for Cigarette Dependence at the end of study/early termination are presented. The Fagerstrom Test for Nicotine Dependence consists of Yes/No and multiple-choice questions where each response is assigned a value from 0 to 1 (for yes/no questions) or 0 to 3 (for multiple-choice questions). Values are summed to yield a total score with a minimum score of 0 points and a maximum score of 10 points. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Baseline = Visit 3 (Day 8) value Population: Per-Protocol
Time frame: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quit Attempts (Per-Protocol)
Count of Test and Control subjects that reported an increase, decrease or no change in quit attempts from Baseline to End of Study are presented. Results for the number of self-reported attempts to quit smoking in the previous 30 days were collected from subject responses to the question "How many times during the past 30 days have you stopped smoking cigarettes for 24 hours or longer because you were trying to quit?". Baseline = Visit 2 values. Population: Per-Protocol.
Time frame: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Count of Subjects in Subgroups Based on Change From Baseline to End of Study on Change in Quitting Intentions (Per-Protocol)
Count of Test and Control subjects that reported a change (No to Yes) or no change in quitting intentions from Baseline to End of Study are presented. Results were collected from subject Yes/No responses to the question "Are you planning to quit smoking in the next 30 days?". Baseline = Visit 2 responses. Population: Per-Protocol.
Time frame: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary total NNAL exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary nicotine equivalents exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary S-phenylmercapturic acid \[S-PMA\] exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Difference in Means of Carboxyhemoglobin (COHb) Exposure Between Day 1 and Day 8 (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean blood carboxyhemoglobin \[COHb\] exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean exhaled carbon monoxide \[CO\] between two methods for determining daily product use (Cigarettes Per Day, CPD) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Difference in Cigarettes Per Day Between the Once Weekly Recall at Day 8 (From Questionnaire) and the Average Daily Tracking Days 2 Through 8 (From IVRS) (Per-Protocol)
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in product use (Cigarettes Per Day \[CPD\]), including test product, between two methods for determining CPD during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Frequency and Percentage of Subjects With Change From Baseline in Cigarette Consumption
Change in cigarette consumption, categorized as 'No change', '\<50% reduction', '50% to \< 100% reduction', '100% reduction' or 'Increase', among subjects in Test and Control groups are presented. Baseline values are based on the average of daily values for the week prior to randomization (Visit 3/Day 8±1).
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)
Frequency and Percentage of Subjects With Change From Baseline in Urinary Total NNAL (ng / g Creatinine)
Change in Urinary Total NNAL, categorized as 'No change', 'Reduction', 'Increase' or 'Missing', among subjects in Test and Control groups are presented. Baseline values are Visit 3 (Day 8) values.
Time frame: Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)
Frequency and Percentage of Subjects With Change From Baseline in Quitting Intentions
Change in subject quitting intentions from Baseline to End of Study are presented. Subject responses were categorized as 'No to Yes', 'Yes to No' and 'Same' (no change in quitting intention). Baseline = Visit 2 (Day 1)
Time frame: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8)
Summary statistics of average cigarettes smoked per day \[CPD\] over previous 7 days collected from Cigarette Use questionnaire on Visit 2 (Day 1) and Visit 3 (Day 8) are presented.
Time frame: Day 1 (Visit 2) and Day 8 (Visit 3)
Summary Statistics of Carboxyhemoglobin by Study Group and Cigarette Consumption Categories Over Visits
Summary statistics of blood carboxyhemoglobin in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
Time frame: Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)
Summary Statistics of Exhaled Carbon Monoxide by Study Group and Cigarette Consumption Categories Over Visits
Summary Statistics of exhaled carbon monoxide in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
Time frame: Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)
Summary Statistics of S-PMA by Study Group and Cigarette Consumption Categories Over Visits
Summary statistics of urinary S-PMA (ng/g creatinine) in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
Time frame: Day 1 (Visit 2), Day 8 (Visit 3), Day 15 (Visit 4), Day 22 (Visit 5), Day 29 (Visit 6) and Day 36 (Visit 7)
Descriptive Statistics for Cigarettes Smoked Per Day (CPD) (Recall Data) in Day 1 and 8 (Respectively) by Study Group and Cigarette Consumption Categories
Descriptive statistics for Cigarettes Smoked per Day (CPD) in Day 1 (Visit 2) and Day 8 (Visit 3) in Test and Control groups using recall data are presented. Subjects were sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing').
Time frame: Day 1 (Visit 2) and Day 8 (Visit 3)
Summary Statistics of Cigarettes Smoked Per Day (IVRS Data) by Study Group and Cigarette Consumption Categories on Days 1 Through 8
Summary Statistics of Cigarettes Smoked per Day collected by IVRS Data method on Days 1 to 8 for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
Time frame: Daily during Baseline Period (Day 1 to Day 8)
Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group
Median change from baseline to End of Study for urinary total NNAL in Test and Control groups are presented. Baseline = Day 8 (Visit 3) values.
Time frame: Day 8 (Visit 3) and End of Study (Day 36±1)
Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group and Cigarette Consumption Categories
Median Change from baseline to End of Study for urinary total NNAL in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Day 8 (Visit 3) values
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits
Change from Baseline to End of Study summary statistics of urinary total NNAL (ng/g Creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Percent Change From Baseline to End of Study Summary Statistics of Urinary Total NNAL (%) by Study Group and Cigarette Consumption Categories Over Visits
Percent change from Baseline to End of study summary statistics of urinary total NNAL (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (mg/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits
Change from Baseline to End of Study summary statistics of urinary nicotine equivalents (mg/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Percent Change From Baseline to End of Study Summary Statistics of Nicotine Equivalents (%) by Study Group and Cigarette Consumption Categories Over Visits
Percent change from Baseline to End of study summary statistics of urinary nicotine equivalents (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Change From Baseline to End of Study Summary Statistics of S-PMA (ng/g Creatinine) by Study Group and Cigarette Consumption Categories Over Visits
Change from Baseline to End of Study summary statistics of urinary S-phenyl mercapturic acid \[S-PMA\] (ng/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Percent Change From Baseline to End of Study Summary Statistics of S-PMA (%) by Study Group and Cigarette Consumption Categories Over Visits
Percent change from Baseline to End of study summary statistics of urinary S-phenyl mercapturic acid \[S-PMA\] (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits
Change from Baseline to End of Study summary statistics of blood carboxyhemoglobin (%) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Percent Change From Baseline to End of Study Summary Statistics of Carboxyhemoglobin (%) by Study Group and Cigarette Consumption Categories Over Visits
Percent change from Baseline to End of study summary statistics of blood carboxyhemoglobin (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (Ppm) by Study Group and Cigarette Consumption Categories Over Visits
Change from Baseline to End of Study summary statistics of exhaled carbon monoxide (ppm) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Percent Change From Baseline to End of Study Summary Statistics of Exhaled Carbon Monoxide (%) by Study Group and Cigarette Consumption Categories Over Visits
Percent change from Baseline to End of study summary statistics of exhaled carbon monoxide for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
Time frame: Day 8 (Visit 3) and Day 36 (Visit 7/End of Study)
Characterization of Subgroups Based on Change From Baseline in Total NNAL
Statistical analyses on the number of subjects in subgroups based on urinary total NNAL change from baseline to the last visit are presented. Baseline = Visit 3 values.
Time frame: Day 36 (Visit 7/End of Study) relative to the start of the baseline period (Visit 2/Day 1)
| Milestone | Test (ad Libitum VERVE® Discs Blue Mint [VBM-FG2] Use) | Control (no VBM-FG2) |
|---|---|---|
| Started | 92 | 62 |
| Completed | 89 | 57 |
| Not completed | 3 | 5 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 |
Summary statistics of percent change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a Statistical Analysis System (SAS®) procedure.
| percent change from baseline | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | 3.8 ± 34.11 | 13.8 ± 45.56 |
| Visit 5 | 12.5 ± 60.16 | 30.4 ± 63.66 |
| Visit 6 | 16.0 ± 50.87 | 29.2 ± 46.70 |
| End of Study/Early Termination | 15.4 ± 62.42 | 28.4 ± 57.66 |
Summary statistics of change from baseline for urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol \[NNAL\] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
| ng/g | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | 14.99 ± 212.505 | 9.47 ± 207.308 |
| Visit 5 | 70.90 ± 436.326 | 76.50 ± 310.423 |
| Visit 6 | 66.23 ± 303.806 | 117.69 ± 289.763 |
| End of Study/Early Termination | 81.33 ± 345.110 | 86.53 ± 209.749 |
Summary statistics of change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (mg/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
| mg/g | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | -0.6 ± 5.28 | 0.6 ± 6.45 |
| Visit 5 | 1.9 ± 8.46 | 2.5 ± 6.48 |
| Visit 6 | 1.1 ± 8.03 | 4.3 ± 9.47 |
| End of Study/Early Termination | 2.6 ± 9.75 | 3.6 ± 6.89 |
Summary statistics of percent change from Baseline for urinary nicotine equivalents including nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
| percent change from baseline | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | 3.2 ± 37.85 | 14.8 ± 51.81 |
| Visit 5 | 18.7 ± 57.95 | 26.3 ± 50.78 |
| Visit 6 | 15.7 ± 54.02 | 30.8 ± 53.08 |
| End of Study/Early Termination | 25.2 ± 65.08 | 35.5 ± 60.54 |
Summary statistics of change from Baseline for urinary S-phenyl mercapturic acid \[S-PMA\] (ng/g creatinine) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
| ng/g | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | 506.33 ± 3150.049 | 242.66 ± 2846.817 |
| Visit 5 | 1129.88 ± 4867.996 | 809.04 ± 3649.614 |
| Visit 6 | 1102.42 ± 4045.946 | 1637.29 ± 4348.050 |
| End of Study/Early Termination | 903.49 ± 4985.072 | 1160.48 ± 2798.644 |
Summary statistics of percent change from Baseline for urinary S-phenyl mercapturic acid \[S-PMA\] (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
| percent change from baseline | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | 17.5 ± 67.39 | 21.1 ± 77.37 |
| Visit 5 | 13.4 ± 67.41 | 38.2 ± 69.68 |
| Visit 6 | 19.7 ± 60.60 | 44.4 ± 87.87 |
| End of Study/Early Termination | 20.9 ± 76.27 | 39.1 ± 70.93 |
Summary statistics of change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
| percent saturation of carboxyhemoglobin | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | -0.42 ± 1.449 | 0.03 ± 1.460 |
| Visit 5 | -0.24 ± 1.418 | 0.39 ± 1.374 |
| Visit 6 | -0.02 ± 1.547 | 0.39 ± 1.299 |
| End of Study/Early Termination | -0.61 ± 1.387 | -0.10 ± 1.118 |
Summary statistics of percent change from Baseline for blood carboxyhemoglobin (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
| percent change from baseline | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | -6.3 ± 27.48 | 5.3 ± 35.59 |
| Visit 5 | -4.0 ± 26.17 | 9.8 ± 27.21 |
| Visit 6 | 1.4 ± 28.26 | 11.3 ± 29.44 |
| End of Study/Early Termination | -9.3 ± 27.89 | 0.7 ± 25.53 |
Summary statistics of change from Baseline for exhaled carbon monoxide (ppm) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
| ppm | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | -1.4 ± 9.41 | -0.2 ± 7.84 |
| Visit 5 | -1.9 ± 7.48 | 0.7 ± 8.37 |
| Visit 6 | -0.8 ± 9.30 | 0.6 ± 7.89 |
| End of Study/Early Termination | -2.3 ± 9.17 | -0.8 ± 6.90 |
Summary statistics of percent change from Baseline for exhaled carbon monoxide (%) in each study visit are presented. Baseline taken from Visit 3 (Day 8±1) value. Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1 Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing this calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS® procedure.
| percent change from baseline | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | -0.8 ± 44.65 | 12.0 ± 65.86 |
| Visit 5 | -5.8 ± 37.05 | 11.4 ± 54.87 |
| Visit 6 | 3.5 ± 49.07 | 13.9 ± 57.42 |
| End of Study/Early Termination | -3.1 ± 47.00 | 9.0 ± 66.04 |
Summary statistics of change from Baseline in number or products used day in each study visit are presented. Values for visit are the average of daily values for the previous week Visit 4 = Day 15±1 Visit 5 = Day 22±1 Visit 6 = Day 29±1 Visit 7/End of Study = Day 36±1
| cigarettes per day | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | -2.7 ± 3.28 | 0.5 ± 1.96 |
| Visit 5 | -3.1 ± 4.34 | 0.3 ± 2.37 |
| Visit 6 | -2.9 ± 4.41 | 0.3 ± 2.78 |
| End of Study/Early Termination | -3.5 ± 4.78 | 0.4 ± 2.76 |
Summary statistics of percent change from Baseline of number of products used per day in each study visit are presented. CPD was tracked using an interactive voice response system (IVRS). During the Baseline Period (Days 1 to 8), subjects reported CPD daily through an IVRS each day between 16:00 and 19:00. Test and Control subjects continued daily tobacco use tracking via an IVRS and return to the study site once a week during the 4 week Product Use Period on Days 15, 22, 29, and 36. Mean percent change from baseline is the mean of all individual subjects' percent change from baseline values. Each percent change from baseline was calculated by subtracting the individual subject's baseline value from the value at the desired timepoint and then dividing the calculated value by the individual subject's baseline value and multiplying by 100. These individual subjects' percent changes from baseline values were used to calculate the mean percent change from baseline using a SAS procedure.
| percent change from baseline | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Visit 4 | -15.0 ± 19.30 | 3.1 ± 10.85 |
| Visit 5 | -16.5 ± 26.21 | 2.9 ± 15.18 |
| Visit 6 | -16.3 ± 24.78 | 2.9 ± 18.01 |
| End of Study/Early Termination | -19.2 ± 27.03 | 3.2 ± 17.28 |
Summary statistics of change from Baseline for Total Score of Fagerstrom Test for Cigarette Dependence at the end of study/early termination are presented. The Fagerstrom Test for Nicotine Dependence consists of Yes/No and multiple-choice questions where each response is assigned a value from 0 to 1 (for yes/no questions) or 0 to 3 (for multiple-choice questions). Values are summed to yield a total score with a minimum score of 0 points and a maximum score of 10 points. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Baseline = Visit 3 (Day 8) value Population: Per-Protocol
| scores on a scale | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Summary Statistics of Change From Baseline for Total Score of Fagerstrom Test for Cigarette Dependence (Per-Protocol Population) | -0.4 ± 1.66 | 0.0 ± 0.82 |
Count of Test and Control subjects that reported an increase, decrease or no change in quit attempts from Baseline to End of Study are presented. Results for the number of self-reported attempts to quit smoking in the previous 30 days were collected from subject responses to the question "How many times during the past 30 days have you stopped smoking cigarettes for 24 hours or longer because you were trying to quit?". Baseline = Visit 2 values. Population: Per-Protocol.
| Participants | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Increase | 4 | 0 |
| No Change | 82 | 53 |
| Decrease | 1 | 2 |
Count of Test and Control subjects that reported a change (No to Yes) or no change in quitting intentions from Baseline to End of Study are presented. Results were collected from subject Yes/No responses to the question "Are you planning to quit smoking in the next 30 days?". Baseline = Visit 2 responses. Population: Per-Protocol.
| Participants | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| No to Yes | 12 | 5 |
| Same | 74 | 45 |
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary total NNAL exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
| ng/g | Day 1 (Weekly Recall) | Day 8 (Daily Tracking Using IVRS) |
|---|---|---|
| Difference in Means of Urinary Total NNAL Exposure Between Day 1 and Day 8 (Per-Protocol) | 485.0 ± 348.45 | 495.0 ± 358.54 |
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary nicotine equivalents exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide) Population: Per-Protocol.
| mg/g | Day 1 (Weekly Recall) | Day 8 (Daily Tracking Using IVRS) |
|---|---|---|
| Difference in Means of Nicotine Equivalents Exposure Between Day 1 and Day 8 (Per-Protocol) | 13.29 ± 9.138 | 13.74 ± 9.049 |
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean urinary S-phenylmercapturic acid \[S-PMA\] exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
| ng/g | Day 1 (Weekly Recall) | Day 8 (Daily Tracking Using IVRS) |
|---|---|---|
| Difference in Means of S-PMA Exposure Between Day 1 and Day 8 (Per-Protocol) | 5773 ± 5786.3 | 5567 ± 5222.3 |
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean blood carboxyhemoglobin \[COHb\] exposure between two methods for determining daily product use (Cigarettes Per Day \[CPD\]) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
| percent saturation of carboxyhemoglobin | Day 1 (Weekly Recall) | Day 8 (Daily Tracking Using IVRS) |
|---|---|---|
| Difference in Means of Carboxyhemoglobin (COHb) Exposure Between Day 1 and Day 8 (Per-Protocol) | 5.4 ± 2.13 | 5.4 ± 1.96 |
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in mean exhaled carbon monoxide \[CO\] between two methods for determining daily product use (Cigarettes Per Day, CPD) during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
| ppm | Day 1 (Weekly Recall) | Day 8 (Daily Tracking Using IVRS) |
|---|---|---|
| Difference in Means of Carbon Monoxide (CO) Exposure Between Day 1 and Day 8 (Per-Protocol) | 22 ± 10.0 | 22 ± 10.3 |
This secondary objective was to compare differences in the biomarker of exposure between two methods for determining CPD during the Baseline Period. Difference in product use (Cigarettes Per Day \[CPD\]), including test product, between two methods for determining CPD during the Baseline Period: Method 1: Recall of average daily CPD for prior week using Past 7 Day Cigarettes Use Questionnaire (Day 1). Method 2: Daily CPD tracking using an interactive voice response system (IVRS; 7 day average of values recorded on Days 2 through 8). Population: Per-Protocol.
| cigarettes per day | Day 1 (Weekly Recall) | Day 8 (Daily Tracking Using IVRS) |
|---|---|---|
| Difference in Cigarettes Per Day Between the Once Weekly Recall at Day 8 (From Questionnaire) and the Average Daily Tracking Days 2 Through 8 (From IVRS) (Per-Protocol) | 19 ± 6.4 | 19 ± 6.3 |
Change in cigarette consumption, categorized as 'No change', '\<50% reduction', '50% to \< 100% reduction', '100% reduction' or 'Increase', among subjects in Test and Control groups are presented. Baseline values are based on the average of daily values for the week prior to randomization (Visit 3/Day 8±1).
| Participants | Test (Visit 4) | Control (Visit 4) | Test (Visit 5) | Control (Visit 5) | Test (Visit 6) | Control (Visit 6) | Test (End of Study) | Control (End of Study) |
|---|---|---|---|---|---|---|---|---|
| No Change | 5 | 3 | 6 | 4 | 6 | 4 | 8 | 2 |
| <50% Reduction | 67 | 22 | 62 | 21 | 56 | 25 | 57 | 24 |
| 50% to < 100% | 3 | 0 | 3 | 0 | 7 | 0 | 8 | 0 |
| 100% Reduction | 0 | 0 | 2 | 0 | 1 | 0 | 2 | 0 |
| Increase | 12 | 30 | 14 | 30 | 17 | 26 | 10 | 29 |
Change in Urinary Total NNAL, categorized as 'No change', 'Reduction', 'Increase' or 'Missing', among subjects in Test and Control groups are presented. Baseline values are Visit 3 (Day 8) values.
| Participants | Test (Visit 4) | Control (Visit 4) | Test (Visit 5) | Control (Visit 5) | Test (Visit 6) | Control (Visit 6) | Test (End of Study) | Control (End of Study) |
|---|---|---|---|---|---|---|---|---|
| No Change | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Reduction | 45 | 25 | 40 | 18 | 33 | 16 | 38 | 18 |
| Increase | 35 | 28 | 43 | 33 | 46 | 37 | 46 | 36 |
| Missing | 7 | 2 | 4 | 4 | 8 | 2 | 3 | 1 |
Change in subject quitting intentions from Baseline to End of Study are presented. Subject responses were categorized as 'No to Yes', 'Yes to No' and 'Same' (no change in quitting intention). Baseline = Visit 2 (Day 1)
| Participants | Test | Control |
|---|---|---|
| No to Yes | 12 | 5 |
| Yes to No | 0 | 0 |
| Same | 74 | 45 |
Summary statistics of average cigarettes smoked per day \[CPD\] over previous 7 days collected from Cigarette Use questionnaire on Visit 2 (Day 1) and Visit 3 (Day 8) are presented.
| cigarettes per day | Test (Visit 2) | Control (Visit 2) | Test (Visit 3) | Control (Visit 3) |
|---|---|---|---|---|
| Summary Statistics of Cigarettes Smoked Per Day on Visits 2 (Day 1) and 3 (Day 8) | 17.7 ± 6.04 | 19.8 ± 7.64 | 17.6 ± 5.36 | 20.0 ± 7.43 |
Summary statistics of blood carboxyhemoglobin in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
| percent saturation of carboxyhemoglobin | Test (Visit 2) | Control (Visit 2) | Test (Visit 3) | Control (Visit 3) | Test (Visit 4) | Control (Visit 4) | Test (Visit 5) | Control (Visit 5) | Test (Visit 6) | Control (Visit 6) | Test (End of Study) | Control (End of Study) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Increase | 6.5 ± 2.61 | 5.5 ± 2.10 | 6.6 ± 2.15 | 5.3 ± 1.63 | 6.2 ± 2.15 | 5.5 ± 1.65 | 6.8 ± 2.46 | 6.1 ± 2.26 | 6.6 ± 2.15 | 5.8 ± 2.07 | 6.0 ± 1.80 | 5.4 ± 1.79 |
| No Change | 4.7 ± 1.57 | 3.9 ± 0.14 | 5.7 ± 2.15 | 3.7 ± 2.19 | 5.2 ± 1.73 | 3.3 ± 0.14 | 5.2 ± 1.76 | 3.2 ± 0.07 | 4.9 ± 1.42 | 5.6 ± 3.11 | 5.0 ± 1.28 | 4.6 ± 1.41 |
| <50% Reduction | 5.5 ± 2.01 | 5.0 ± 2.35 | 5.4 ± 1.92 | 5.0 ± 2.18 | 5.2 ± 2.05 | 4.8 ± 2.15 | 5.4 ± 2.24 | 5.0 ± 2.08 | 5.8 ± 2.28 | 5.1 ± 1.82 | 5.1 ± 2.07 | 4.6 ± 1.85 |
| 50% to < 100% Reduction | 5.0 ± 2.5 | — | 5.4 ± 2.16 | — | 4.7 ± 2.03 | — | 4.4 ± 1.98 | — | 3.7 ± 1.90 | — | 3.2 ± 1.87 | — |
| 100% Reduction | 4.5 ± 0.14 | — | 4.5 ± 0.35 | — | 2.0 ± 0.64 | — | 1.2 ± 0.21 | — | 1.2 ± 0.00 | — | 1.5 ± 0.21 | — |
| Missing | 3.5 ± 1.63 | — | 4.3 ± 2.33 | — | 2.2 ± 0.14 | — | 3.3 ± 1.98 | — | 4.1 ± 1.91 | — | 3.7 ± 0.92 | — |
| Overall | 5.4 ± 2.11 | 5.3 ± 2.18 | 5.5 ± 1.99 | 5.1 ± 1.90 | 5.1 ± 2.10 | 5.1 ± 1.91 | 5.3 ± 2.32 | 5.5 ± 2.23 | 5.5 ± 2.33 | 5.5 ± 1.98 | 4.9 ± 2.07 | 5.0 ± 1.82 |
Summary Statistics of exhaled carbon monoxide in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
| ppm | Test (Visit 2) | Control (Visit 2) | Test (Visit 3) | Control (Visit 3) | Test (Visit 4) | Control (Visit 4) | Test (Visit 5) | Control (Visit 5) | Test (Visit 6) | Control (Visit 6) | Test (End of Study) | Control (End of Study) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Increase | 28.3 ± 11.13 | 21.0 ± 9.65 | 29.6 ± 12.12 | 20.6 ± 9.11 | 28.5 ± 15.29 | 21.4 ± 8.57 | 28.1 ± 13.60 | 22.7 ± 13.28 | 27.8 ± 12.32 | 21.8 ± 10.44 | 25.9 ± 8.86 | 20.2 ± 9.54 |
| No Change | 17.3 ± 10.77 | 15.5 ± 3.54 | 22.5 ± 9.56 | 11.5 ± 10.61 | 21.6 ± 8.88 | 12.0 ± 4.24 | 22.4 ± 10.88 | 11.5 ± 2.12 | 19.3 ± 9.82 | 18.0 ± 9.90 | 21.5 ± 9.96 | 18.5 ± 2.12 |
| <50% Reduction | 22.2 ± 9.21 | 22.3 ± 10.87 | 21.6 ± 10.01 | 21.0 ± 11.13 | 20.9 ± 11.16 | 19.4 ± 10.89 | 20.5 ± 10.25 | 19.9 ± 9.98 | 23.0 ± 11.32 | 20.4 ± 9.24 | 21.1 ± 10.09 | 19.1 ± 8.71 |
| 50% to < 100% Reduction | 19.3 ± 12.14 | — | 20.6 ± 9.86 | — | 18.0 ± 8.83 | — | 15.5 ± 8.38 | — | 12.1 ± 8.54 | — | 9.9 ± 6.08 | — |
| 100% Reduction | 20.0 ± 5.66 | — | 17.0 ± 4.24 | — | 4.5 ± 0.71 | — | 2.5 ± 0.71 | — | 5.5 ± 2.12 | — | 4.0 ± 2.83 | — |
| Missing | 20.5 ± 14.85 | — | 18.5 ± 16.26 | — | 10.5 ± 2.12 | — | 9.5 ± 6.36 | — | 15.5 ± 12.02 | — | 13.0 ± 8.49 | — |
| Overall | 22.1 ± 10.05 | 21.4 ± 10.03 | 22.4 ± 10.40 | 20.4 ± 10.05 | 21.0 ± 11.68 | 20.2 ± 9.62 | 20.5 ± 11.18 | 21.1 ± 11.81 | 21.7 ± 11.71 | 21.0 ± 9.77 | 20.1 ± 10.41 | 19.7 ± 8.94 |
Summary statistics of urinary S-PMA (ng/g creatinine) in each visit among subjects in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
| ng/g | Test (Visit 2) | Control (Visit 2) | Test (Visit 3) | Control (Visit 3) | Test (Visit 4) | Control (Visit 4) | Test (Visit 5) | Control (Visit 5) | Test (Visit 6) | Control (Visit 6) | Test (End of Study) | Control (End of Study) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Increase | 7331.62 ± 6411.996 | 5283.78 ± 4744.807 | 5731.61 ± 5064.881 | 4934.00 ± 4812.350 | 6793.00 ± 6076.280 | 5961.02 ± 5470.426 | 7572.53 ± 9023.363 | 6342.74 ± 5917.203 | 5863.90 ± 5274.304 | 7369.19 ± 6552.358 | 8389.80 ± 6625.523 | 6358.61 ± 5253.083 |
| No Change | 5283.54 ± 4043.599 | 5743.41 ± 2819.277 | 4216.93 ± 2660.723 | 6930.38 ± 5483.666 | 6412.49 ± 4323.454 | 5649.83 ± 1833.540 | 6158.33 ± 5186.584 | 6108.42 ± 1258.428 | 8118.69 ± 5998.806 | 4683.26 ± 7.859 | 4352.99 ± 3873.342 | 8688.22 ± 3272.243 |
| <50% Reduction | 6422.25 ± 6830.753 | 5449.38 ± 5289.323 | 6495.06 ± 5936.803 | 5356.63 ± 5359.524 | 6848.24 ± 6467.601 | 5315.31 ± 6041.242 | 7836.17 ± 8644.447 | 5399.55 ± 4159.097 | 8304.71 ± 8562.548 | 6567.55 ± 7807.345 | 7335.57 ± 7068.643 | 6481.35 ± 6132.009 |
| 50% to < 100% Reduction | 2925.07 ± 3765.497 | — | 5352.66 ± 8413.472 | — | 5151.19 ± 6608.284 | — | 4892.41 ± 7615.700 | — | 7230.42 ± 9546.409 | — | 9795.94 ± 12602.08 | — |
| 100% Reduction | 5647.56 ± 1738.940 | — | 5510.19 ± 123.439 | — | 2265.42 ± 2731.172 | — | 731.08 | — | 533.76 ± 461.885 | — | 440.59 ± 225.383 | — |
| Missing | 2389.46 ± 964.418 | — | 2693.13 ± 1334.197 | — | 2482.52 ± 208.398 | — | 2450.90 ± 1729.041 | — | 2144.28 ± 1851.862 | — | 2896.76 ± 1518.588 | — |
| Overall | 6072.78 ± 6251.565 | 5374.40 ± 4875.645 | 5991.56 ± 5741.490 | 5195.78 ± 4999.201 | 6431.69 ± 6100.377 | 5677.37 ± 5562.787 | 7151.83 ± 8160.286 | 5928.95 ± 5068.858 | 7525.25 ± 7893.011 | 6926.73 ± 6941.824 | 7098.86 ± 7113.465 | 6502.50 ± 5540.461 |
Descriptive statistics for Cigarettes Smoked per Day (CPD) in Day 1 (Visit 2) and Day 8 (Visit 3) in Test and Control groups using recall data are presented. Subjects were sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing').
| cigarettes per day | Test (Visit 2) | Control (Visit 2) | Test (Visit 3) | Control (Visit 3) |
|---|---|---|---|---|
| Increase | 15.6 ± 4.12 | 19.7 ± 8.52 | 16.1 ± 4.68 | 19.9 ± 8.47 |
| No Change | 19.5 ± 8.80 | 20.0 ± 0.00 | 17.6 ± 8.28 | 20.0 ± 0.00 |
| <50% Reduction | 18.4 ± 5.97 | 19.8 ± 6.96 | 18.2 ± 4.94 | 20.2 ± 6.36 |
| 50% to < 100% Reduction | 16.0 ± 6.54 | — | 16.8 ± 5.85 | — |
| 100% Reduction | 12.5 ± 3.54 | — | 11.0 ± 2.83 | — |
| Missing | 15.0 ± 7.07 | — | 20.0 | — |
| Overall | 17.7 ± 6.04 | 19.8 ± 7.64 | 17.6 ± 5.36 | 20.0 ± 7.43 |
Summary Statistics of Cigarettes Smoked per Day collected by IVRS Data method on Days 1 to 8 for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented.
| cigarettes per day | Test (Day 1) | Control (Day 1) | Test (Day 2) | Control (Day 2) | Test (Day 3) | Control (Day 3) | Test (Day 4) | Control (Day 4) | Test (Day 5) | Control (Day 5) | Test (Day 6) | Control (Day 6) | Test (Day 7) | Control (Day 7) | Test (Day 8) | Control (Day 8) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Increase | 16.5 ± 3.67 | 19.1 ± 8.04 | 15.4 ± 4.42 | 17.4 ± 8.39 | 17.0 ± 5.13 | 20.00 ± 8.66 | 17.0 ± 5.34 | 20.3 ± 8.49 | 15.8 ± 5.31 | 19.4 ± 9.63 | 15.8 ± 7.91 | 20.7 ± 9.82 | 15.4 ± 9.06 | 18.4 ± 8.75 | 17.5 ± 7.67 | 19.3 ± 8.58 |
| No Change | 17.4 ± 8.43 | 20.0 ± 0.00 | 18.7 ± 8.30 | 20.0 ± 0.00 | 17.4 ± 8.40 | 20.0 ± 0.00 | 17.6 ± 8.28 | 20.0 | 18.4 ± 8.52 | 20.0 | 17.1 ± 8.54 | 20.0 ± 0.00 | 17.5 ± 8.33 | 20.0 ± 0.00 | 17.3 ± 8.48 | 20.0 ± 0.00 |
| <50% Reduction | 19.1 ± 5.92 | 17.4 ± 7.12 | 17.9 ± 5.50 | 19.1 ± 6.48 | 17.3 ± 5.06 | 20.6 ± 6.45 | 18.8 ± 5.42 | 21.2 ± 7.06 | 17.8 ± 5.64 | 20.8 ± 8.30 | 17.9 ± 5.77 | 19.1 ± 5.77 | 18.9 ± 5.39 | 18.8 ± 6.74 | 18.6 ± 5.21 | 19.0 ± 6.87 |
| 50% to < 100% Reduction | 18.4 ± 8.22 | — | 16.2 ± 5.85 | — | 19.1 ± 6.28 | — | 17.4 ± 5.66 | — | 18.6 ± 5.62 | — | 18.3 ± 8.88 | — | 17.4 ± 10.44 | — | 19.0 ± 5.86 | — |
| 100% Reduction | 8.5 ± 4.95 | — | 11.5 ± 4.95 | — | 8.5 ± 2.12 | — | 10.0 | — | — | — | 15.0 ± 0.00 | — | 11.5 ± 3.54 | — | 11.0 ± 5.66 | — |
| Missing | 15.0 ± 7.07 | — | 15.0 ± 7.07 | — | 15.5 ± 6.36 | — | 16.0 ± 5.66 | — | 17.0 ± 7.07 | — | 17.0 ± 7.07 | — | 21.0 ± 12.73 | — | 17.5 ± 10.61 | — |
| Overall | 18.2 ± 6.26 | 18.4 ± 7.49 | 17.3 ± 5.72 | 18.2 ± 7.41 | 17.2 ± 5.68 | 20.2 ± 7.46 | 18.1 ± 5.74 | 20.7 ± 7.79 | 17.6 ± 5.83 | 20.0 ± 8.87 | 17.4 ± 6.37 | 20.0 ± 7.96 | 18.0 ± 6.93 | 18.7 ± 7.48 | 18.2 ± 6.01 | 19.2 ± 7.63 |
Median change from baseline to End of Study for urinary total NNAL in Test and Control groups are presented. Baseline = Day 8 (Visit 3) values.
| ng/g | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Median Change From Baseline to End of Study for Urinary Total NNAL by Study Group | 472.893 (42.92 to 2072.61) | 395.108 (41.9 to 1524.88) | 444.709 (16.53 to 2851.85) | 476.795 (59.67 to 1558.82) | 5.448 (-564.08 to 1872.75) | 70.129 (-408.32 to 683.71) |
Median Change from baseline to End of Study for urinary total NNAL in Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Day 8 (Visit 3) values
| ng/g | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 548.817 (103.304 to 1289.911) | 415.790 (75.406 to 1238.478) | 719.799 (252.923 to 1424.581) | 489.729 (59.671 to 1188.119) | 168.889 (-36.828 to 376.475) | 67.998 (-325.835 to 638.215) |
| No Change | 499.544 (132.328 to 843.698) | 789.559 (54.238 to 1524.880) | 376.087 (175.045 to 590.850) | 592.508 (68.451 to 1116.564) | 30.576 (-467.611 to 54.268) | -197.051 (-408.315 to 14.213) |
| <50% Reduction | 516.752 (42.916 to 2072.612) | 356.857 (41.901 to 1431.914) | 444.709 (18.574 to 2050.275) | 467.615 (84.686 to 1558.824) | 1.776 (-564.082 to 1208.177) | 73.507 (-111.025 to 683.712) |
| 50% to < 100% Reduction | 375.183 (57.698 to 979.102) | — | 263.677 (62.899 to 2851.852) | — | -48.425 (-365.303 to 1872.750) | — |
| 100% Reduction | 158.649 (157.063 to 160.236) | — | 28.686 (16.528 to 40.844) | — | -129.963 (-140.535 to -119.392) | — |
| Missing | 303.452 (124.886 to 482.019) | — | 268.140 (146.165 to 390.115) | — | -35.312 (-91.904 to 21.279) | — |
| Overall | 472.893 (42.916 to 2072.612) | 395.108 (41.901 to 1524.880) | 444.709 (16.528 to 2851.852) | 476.795 (59.671 to 1558.824) | 5.448 (-564.082 to 1872.750) | 70.129 (-408.315 to 683.712) |
Change from Baseline to End of Study summary statistics of urinary total NNAL (ng/g Creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
| ng/g | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 551.02 ± 318.270 | 440.36 ± 261.806 | 721.93 ± 327.377 | 538.09 ± 287.478 | 158.11 ± 140.443 | 92.60 ± 227.975 |
| No Change | 456.39 ± 275.603 | 789.56 ± 1039.900 | 389.46 ± 170.153 | 592.51 ± 741.128 | -66.92 ± 185.884 | -197.05 ± 298.772 |
| <50% Reduction | 535.46 ± 393.698 | 487.20 ± 378.047 | 614.61 ± 517.499 | 590.28 ± 451.453 | 88.22 ± 320.921 | 103.08 ± 170.772 |
| 50% to < 100% Reduction | 443.02 ± 343.687 | — | 592.73 ± 932.562 | — | 149.71 ± 713.457 | — |
| 100% Reduction | 158.65 ± 2.244 | — | 28.69 ± 17.194 | — | -129.96 ± 14.950 | — |
| Missing | 303.45 ± 252.531 | — | 268.14 ± 172.499 | — | -35.31 ± 80.032 | — |
| Overall | 507.43 ± 365.172 | 473.50 ± 347.581 | 586.29 ± 525.084 | 563.30 ± 376.309 | 81.33 ± 345.110 | 86.53 ± 209.749 |
Percent change from Baseline to End of study summary statistics of urinary total NNAL (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
| percent change from baseline | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 551.02 ± 318.270 | 440.36 ± 261.806 | 721.93 ± 327.377 | 538.09 ± 287.478 | 43.2 ± 49.11 | 31.7 ± 66.12 |
| No Change | 456.39 ± 275.603 | 789.56 ± 1039.900 | 389.46 ± 170.153 | 592.51 ± 741.128 | -0.3 ± 29.55 | -0.3 ± 37.46 |
| <50% Reduction | 535.46 ± 393.698 | 487.20 ± 378.047 | 614.61 ± 517.499 | 590.28 ± 451.453 | 17.6 ± 63.88 | 26.9 ± 48.80 |
| 50% to < 100% Reduction | 443.02 ± 343.687 | — | 592.73 ± 932.562 | — | 7.3 ± 80.69 | — |
| 100% Reduction | 158.65 ± 2.244 | — | 28.69 ± 17.194 | — | -82.0 ± 10.58 | — |
| Missing | 303.45 ± 252.531 | — | 268.14 ± 172.499 | — | -1.0 ± 25.53 | — |
| Overall | 507.43 ± 365.172 | 473.50 ± 347.581 | 586.29 ± 525.084 | 563.30 ± 376.309 | 15.4 ± 62.42 | 28.4 ± 57.66 |
Change from Baseline to End of Study summary statistics of urinary nicotine equivalents (mg/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values.
| mg/g | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 18.24 ± 14.941 | 13.70 ± 7.870 | 24.84 ± 14.892 | 16.55 ± 6.791 | 6.77 ± 7.432 | 3.73 ± 5.932 |
| No Change | 8.75 ± 4.809 | 8.14 | 10.23 ± 3.053 | 13.62 ± 1.600 | 1.48 ± 3.418 | 6.61 |
| <50% Reduction | 15.00 ± 9.726 | 14.77 ± 10.432 | 16.07 ± 11.551 | 18.07 ± 14.909 | 1.80 ± 9.214 | 3.29 ± 8.011 |
| 50% to < 100% Reduction | 11.51 ± 6.995 | — | 16.62 ± 22.808 | — | 4.89 ± 20.082 | — |
| 100% Reduction | 8.19 ± 1.870 | — | 7.41 | — | -2.11 | — |
| Missing | 9.09 ± 1.956 | — | 8.81 ± 0.629 | — | -0.28 ± 2.585 | — |
| Overall | 14.32 ± 9.996 | 14.06 ± 8.973 | 16.60 ± 13.108 | 17.13 ± 11.092 | 2.59 ± 9.748 | 3.59 ± 6.886 |
Percent change from Baseline to End of study summary statistics of urinary nicotine equivalents (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Nicotine equivalents include nicotine and its 5 metabolites (cotinine, trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-0-glucuronide, nicotine-N-glucuronide, and cotinine-N-glucuronide). Baseline = Visit 3 (Day 8) values.
| percent change from baseline | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 18.24 ± 14.941 | 13.70 ± 7.870 | 24.84 ± 14.892 | 16.55 ± 6.791 | 62.5 ± 69.50 | 41.1 ± 72.40 |
| No Change | 8.75 ± 4.809 | 8.14 | 10.23 ± 3.053 | 13.62 ± 1.600 | 40.0 ± 55.51 | 81.1 |
| <50% Reduction | 15.00 ± 9.726 | 14.77 ± 10.432 | 16.07 ± 11.551 | 18.07 ± 14.909 | 19.0 ± 61.98 | 27.6 ± 46.51 |
| 50% to < 100% Reduction | 11.51 ± 6.995 | — | 16.62 ± 22.808 | — | 15.1 ± 93.59 | — |
| 100% Reduction | 8.19 ± 1.870 | — | 7.41 | — | -22.1 | — |
| Missing | 9.09 ± 1.956 | — | 8.81 ± 0.629 | — | -0.1 ± 28.42 | — |
| Overall | 14.32 ± 9.996 | 14.06 ± 8.973 | 16.60 ± 13.108 | 17.13 ± 11.092 | 25.2 ± 65.08 | 35.5 ± 60.54 |
Change from Baseline to End of Study summary statistics of urinary S-phenyl mercapturic acid \[S-PMA\] (ng/g creatinine) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
| ng/g | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 5731.61 ± 5064.881 | 4934.00 ± 4812.350 | 8389.80 ± 6625.523 | 6358.61 ± 5253.083 | 2410.02 ± 2986.346 | 1341.70 ± 2495.655 |
| No Change | 4216.93 ± 2660.723 | 6930.38 ± 5483.666 | 4352.99 ± 3873.342 | 8688.22 ± 3272.243 | 136.06 ± 3959.381 | 1757.84 ± 2211.423 |
| <50% Reduction | 6495.06 ± 5936.803 | 5356.63 ± 5359.524 | 7335.57 ± 7068.643 | 6481.35 ± 6132.009 | 875.52 ± 4755.856 | 903.68 ± 3218.825 |
| 50% to < 100% Reduction | 5352.66 ± 8413.472 | — | 9795.94 ± 12602.08 | — | 1941.73 ± 11042.40 | — |
| 100% Reduction | 5510.19 ± 123.439 | — | 440.59 ± 225.383 | — | -5069.60 ± 101.944 | — |
| Missing | 2693.13 ± 1334.197 | — | 2896.76 ± 1518.588 | — | 203.64 ± 184.391 | — |
| Overall | 5991.56 ± 5741.490 | 5195.78 ± 4999.201 | 7098.86 ± 7113.465 | 6502.50 ± 5540.461 | 903.49 ± 4985.072 | 1160.48 ± 2798.644 |
Percent change from Baseline to End of study summary statistics of urinary S-phenyl mercapturic acid \[S-PMA\] (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
| percent change from baseline | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 5731.61 ± 5064.881 | 4934.00 ± 4812.350 | 8389.80 ± 6625.523 | 6358.61 ± 5253.083 | 50.0 ± 58.51 | 46.5 ± 76.26 |
| No Change | 4216.93 ± 2660.723 | 6930.38 ± 5483.666 | 4352.99 ± 3873.342 | 8688.22 ± 3272.243 | 16.1 ± 61.36 | 55.3 ± 75.66 |
| <50% Reduction | 6495.06 ± 5936.803 | 5356.63 ± 5359.524 | 7335.57 ± 7068.643 | 6481.35 ± 6132.009 | 19.9 ± 76.46 | 29.4 ± 66.18 |
| 50% to < 100% Reduction | 5352.66 ± 8413.472 | — | 9795.94 ± 12602.08 | — | 30.3 ± 123.78 | — |
| 100% Reduction | 5510.19 ± 123.439 | — | 440.59 ± 225.383 | — | -92.0 ± 3.91 | — |
| Missing | 2693.13 ± 1334.197 | — | 2896.76 ± 1518.588 | — | 6.7 ± 3.53 | — |
| Overall | 5991.56 ± 5741.490 | 5195.78 ± 4999.201 | 7098.86 ± 7113.465 | 6502.50 ± 5540.461 | 20.9 ± 76.27 | 39.1 ± 70.93 |
Change from Baseline to End of Study summary statistics of blood carboxyhemoglobin (%) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
| percent saturation of carboxyhemoglobin | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 6.62 ± 2.151 | 5.31 ± 1.627 | 5.97 ± 1.803 | 5.39 ± 1.786 | -0.65 ± 1.099 | 0.09 ± 1.178 |
| No Change | 5.68 ± 2.153 | 3.65 ± 2.192 | 5.00 ± 1.278 | 4.60 ± 1.414 | -0.68 ± 1.342 | 0.95 ± 0.778 |
| <50% Reduction | 5.40 ± 1.918 | 4.99 ± 2.184 | 5.11 ± 2.066 | 4.57 ± 1.847 | -0.29 ± 1.323 | -0.42 ± 0.986 |
| 50% to < 100% Reduction | 5.36 ± 2.159 | — | 3.21 ± 1.870 | — | -2.15 ± 0.952 | — |
| 100% Reduction | 4.45 ± 0.354 | — | 1.45 ± 0.212 | — | -3.00 ± 0.141 | — |
| Missing | 4.25 ± 2.333 | — | 3.65 ± 0.919 | — | -0.60 ± 1.414 | — |
| Overall | 5.53 ± 1.986 | 5.11 ± 1.897 | 4.91 ± 2.071 | 5.00 ± 1.821 | -0.61 ± 1.387 | -0.10 ± 1.118 |
Percent change from Baseline to End of study summary statistics of blood carboxyhemoglobin (%) for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
| percent change from baseline | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 6.62 ± 2.151 | 5.31 ± 1.627 | 5.97 ± 1.803 | 5.39 ± 1.786 | -7.6 ± 17.41 | 3.6 ± 27.54 |
| No Change | 5.68 ± 2.153 | 3.65 ± 2.192 | 5.00 ± 1.278 | 4.60 ± 1.414 | -4.0 ± 29.21 | 39.6 ± 45.07 |
| <50% Reduction | 5.40 ± 1.918 | 4.99 ± 2.184 | 5.11 ± 2.066 | 4.57 ± 1.847 | -3.7 ± 25.91 | -6.1 ± 18.12 |
| 50% to < 100% Reduction | 5.36 ± 2.159 | — | 3.21 ± 1.870 | — | -42.5 ± 18.66 | — |
| 100% Reduction | 4.45 ± 0.354 | — | 1.45 ± 0.212 | — | -67.5 ± 2.19 | — |
| Missing | 4.25 ± 2.333 | — | 3.65 ± 0.919 | — | -5.9 ± 30.05 | — |
| Overall | 5.53 ± 1.986 | 5.11 ± 1.897 | 4.91 ± 2.071 | 5.00 ± 1.821 | -9.3 ± 27.89 | 0.7 ± 25.53 |
Change from Baseline to End of Study summary statistics of exhaled carbon monoxide (ppm) by Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
| ppm | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 29.64 ± 12.118 | 20.59 ± 9.109 | 25.91 ± 8.860 | 20.21 ± 9.537 | -3.73 ± 10.248 | -0.38 ± 7.894 |
| No Change | 22.50 ± 9.562 | 11.50 ± 10.607 | 21.50 ± 9.957 | 18.50 ± 2.121 | -1.00 ± 9.798 | 7.00 ± 8.485 |
| <50% Reduction | 21.32 ± 10.133 | 20.96 ± 11.126 | 21.13 ± 10.091 | 19.08 ± 8.707 | -0.46 ± 8.466 | -1.88 ± 5.102 |
| 50% to < 100% Reduction | 20.63 ± 9.855 | — | 9.88 ± 6.081 | — | -10.75 ± 8.172 | — |
| 100% Reduction | 17.00 ± 4.243 | — | 4.00 ± 2.828 | — | -13.00 ± 1.414 | — |
| Missing | 18.50 ± 16.263 | — | 13.00 ± 8.485 | — | -5.50 ± 7.778 | — |
| Overall | 22.24 ± 10.491 | 20.42 ± 10.046 | 20.15 ± 10.410 | 19.65 ± 8.939 | -2.28 ± 9.175 | -0.76 ± 6.899 |
Percent change from Baseline to End of study summary statistics of exhaled carbon monoxide for Test and Control groups sub-categorized by cigarette consumption categories obtained from End of Study ('Increase', 'No Change', \>50% Reduction', '50 to \<100% Reduction', '100% Reduction' and 'Missing') are presented. Baseline = Visit 3 (Day 8) values.
| percent change from baseline | Test (Visit 3) | Control (Visit 3) | Test (End of Study) | Control (End of Study) | Test (Change at End of Study/Early Term) | Control (Change at End of Study/Early Term) |
|---|---|---|---|---|---|---|
| Increase | 29.64 ± 12.118 | 20.59 ± 9.109 | 25.91 ± 8.860 | 20.21 ± 9.537 | -7.0 ± 32.63 | 6.8 ± 58.17 |
| No Change | 22.50 ± 9.562 | 11.50 ± 10.607 | 21.50 ± 9.957 | 18.50 ± 2.121 | 6.6 ± 45.21 | 165.1 ± 226.09 |
| <50% Reduction | 21.32 ± 10.133 | 20.96 ± 11.126 | 21.13 ± 10.091 | 19.08 ± 8.707 | 6.0 ± 47.63 | -1.4 ± 40.74 |
| 50% to < 100% Reduction | 20.63 ± 9.855 | — | 9.88 ± 6.081 | — | -49.2 ± 27.25 | — |
| 100% Reduction | 17.00 ± 4.243 | — | 4.00 ± 2.828 | — | -77.9 ± 11.11 | — |
| Missing | 18.50 ± 16.263 | — | 13.00 ± 8.485 | — | -18.3 ± 25.93 | — |
| Overall | 22.24 ± 10.491 | 20.42 ± 10.046 | 20.15 ± 10.410 | 19.65 ± 8.939 | -3.1 ± 47.00 | 9.0 ± 66.04 |
Statistical analyses on the number of subjects in subgroups based on urinary total NNAL change from baseline to the last visit are presented. Baseline = Visit 3 values.
| Participants | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| Increase | 46 | 36 |
| Reduction | 38 | 18 |
Collected over Adverse events were collected from the signature of the Informed Consent Form (ICF) by each subject until the end of the safety follow-up period, for a total of up to 9 weeks from Screening to End of Study per subject.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test (ad Libitum VBM-FG2) | 0/92 (0%) | 0/92 (0%) | 25/92 (27.2%) |
| Control (no VBM-FG2) | 0/62 (0%) | 0/62 (0%) | 7/62 (11.3%) |
| Event | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 6/92 | 2/62 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 4/92 | 1/62 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 3/92 | 2/62 |
| HeadacheNervous system disorders | 3/92 | 2/62 |
| FatigueGeneral disorders | 1/92 | 2/62 |
| Pulmonary congestionRespiratory, thoracic and mediastinal disorders | 2/92 | 0/62 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 2/92 | 0/62 |
| Oral herpesInfections and infestations | 2/92 | 0/62 |
| Upper respiratory tract infectionInfections and infestations | 2/92 | 0/62 |
| DiarrhoeaGastrointestinal disorders | 2/92 | 1/62 |
| Age, Continuous(years) | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) | Total |
|---|---|---|---|
| Mean | 43 (21 to 65) | 42 (21 to 64) | 43 (21 to 65) |
| Sex: Female, Male(Participants) | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) | Total |
|---|---|---|---|
| Female | 48 | 30 | 78 |
| Male | 44 | 32 | 76 |
| Ethnicity (NIH/OMB)(Participants) | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 9 |
| Not Hispanic or Latino | 86 | 59 | 145 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) | Total |
|---|---|---|---|
| Race — Asian | 1 | 0 | 1 |
| Race — Black or African American | 15 | 11 | 26 |
| Race — White | 72 | 47 | 119 |
| Race — Other | 4 | 4 | 8 |
| Body Weight(kg) | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) | Total |
|---|---|---|---|
| Mean | 82.8 ± 20.94 | 85.3 ± 23.56 | 83.8 ± 21.99 |
| Height(cm) | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) | Total |
|---|---|---|---|
| Mean | 170.8 ± 8.32 | 171.1 ± 9.40 | 170.9 ± 8.75 |
| BMI(kg/m^2) | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) | Total |
|---|---|---|---|
| Mean | 28.3 ± 6.69 | 29.0 ± 7.26 | 28.6 ± 6.91 |
| Quit Attempts(Participants) | Test (ad Libitum VBM-FG2) | Control (no VBM-FG2) | Total |
|---|---|---|---|
| Yes | 3 | 3 | 6 |
| No | 89 | 59 | 148 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2013 to primary completion in Nov 2013, 2 months.
Results were first posted in Sep 2024, 10 years 10 months after primary completion.
Of 56 industry-sponsored interventional studies with no phase under Tobacco Use, half reached primary completion within 2 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 5. This study's 2 months is close to that.
Counting every sponsor, half of 223 studies reached it within 16 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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