An interventional study of Low level nicotine cigarette and Intermediate nicotine level cigarette in Smoking, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention
Smoking remains a leading cause of preventable disease and premature death worldwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine in cigarettes to the point that they are rendered non-addictive can potentially be an effective public policy measure that can significantly reduce tobacco-related mortality and morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. Currently, no reduced nicotine cigarettes are available that will allow studying the feasibility of this policy measure. The National Institute on Drug Abuse has contracted with Research Triangle Institute to assist in the development of cigarettes with varying nicotine content that can be made available to researchers. They have established a contract that will result in the manufacture of 9 million cigarettes to be distributed to the research community. Prior to full production, the palatability and nicotine intake of these cigarettes in smokers must be determined.
Phase 3: This descriptive study will use a between subjects, double blind design. This study will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research assistants will be blind to the cigarette type.
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's enrollment of 36 is below the median of 117 across 250 interventional studies indexed under Smoking.
Browse Smoking studies →University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.
Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.
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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.
Exclusion Criteria:
(0.4 mg/g)
Other: Low level nicotine cigarette
(5.7-5.8 mg/g)
Other: Intermediate nicotine level cigarette
(11.4-12.8 mg/g)
Other: High level nicotine cigarette
smoke the study cigarette exclusively for one week
smoke the study cigarette exclusively for one week
smoke the study cigarette exclusively for one week
Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1
Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.
Time frame: Second Visit (Week 1) minus Baseline (Day 1)
Responses on Modified Cigarette Evaluation Scale
Modified Cigarette Evaluation Scale \[CES\] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale.
Time frame: Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)
Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes
Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.
Time frame: Baseline (Day 1) Compared to Second Visit (Week 1)
Comparison of Number of Cigarettes Smoked
Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.
Time frame: 1 week
| Milestone | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette |
|---|---|---|---|
| Started | 13 | 11 | 12 |
| Completed | 12 | 11 | 12 |
| Not completed | 1 | 0 | 0 |
Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.
| nmols/ml | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette |
|---|---|---|---|
| Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1 | -16.2 ± 5.0 | -7.6 ± 4.7 | 1.3 ± 4.4 |
Modified Cigarette Evaluation Scale \[CES\] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale.
| units on a scale | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette |
|---|---|---|---|
| Responses on Modified Cigarette Evaluation Scale | 36.8 ± 4.1 | 54.1 ± 4.1 | 61.4 ± 4.1 |
Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.
| units on a scale | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette |
|---|---|---|---|
| Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes | 56.6 ± 4.6 | 66.7 ± 4.6 | 68.3 ± 4.6 |
Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.
| cigarettes per week | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette |
|---|---|---|---|
| Comparison of Number of Cigarettes Smoked | 92.1 ± 15.9 | 112.8 ± 49.4 | 157.6 ± 15.2 |
Collected over 1 week. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 Low Level Nicotine Cigarette | — | 0/12 (0%) | 0/12 (0%) |
| Arm 2 Intermediate Nicotine Level Cigarette | — | 0/11 (0%) | 0/11 (0%) |
| Arm 3 High Level Nicotine Cigarette | — | 0/12 (0%) | 0/12 (0%) |
Daily cigarette smokers
| Age, Categorical(Participants) | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 11 | 12 | 35 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette | Total |
|---|---|---|---|---|
| Mean | 37.0 ± 12.4 | 32.7 ± 10.8 | 43.6 ± 9.6 | 37.9 ± 11.6 |
| Sex: Female, Male(Participants) | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette | Total |
|---|---|---|---|---|
| Female | 8 | 7 | 5 | 20 |
| Male | 4 | 4 | 7 | 15 |
| Region of Enrollment(participants) | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette | Total |
|---|---|---|---|---|
| United States | 12 | 11 | 12 | 35 |
| Menthol(participants) | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette | Total |
|---|---|---|---|---|
| Menthol | 4 | 3 | 4 | 11 |
| Non Menthol | 8 | 8 | 8 | 24 |
| Cigarettes per day(Cigarettes per day) | Arm 1 Low Level Nicotine Cigarette | Arm 2 Intermediate Nicotine Level Cigarette | Arm 3 High Level Nicotine Cigarette | Total |
|---|---|---|---|---|
| Mean | 16.8 ± 5.1 | 16.1 ± 3.5 | 18.7 ± 4.3 | 17.2 ± 4.4 |
The record gives a start of Feb 2011, a primary completion of Mar 2012 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2017, 4 years 10 months after primary completion.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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