A Phase 3 interventional study of Cognitive behavioral cessation counseling and Counseling and placebo drug intervention in Tobacco Use Cessation, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-29.
Sponsored by Duke University · Phase 3, Interventional, and Prevention
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Among 190 studies in Tobacco Use Cessation with a site in United States — 30 open to participants now, 41 under way, 2 of them phase 3. Tobacco Use Cessation · United States.
Among the 190 studies in Tobacco Use Cessation with a site in United States, this one is the 166th largest by enrollment of the 184 interventional ones that give a count, is one of 8 that started in 2018, is one of 18 in phase 3, and was the 110th registered.
276 studies on the registry are indexed under Tobacco Use Cessation; 45 are open to participants now.
Browse Tobacco Use Cessation studies →30 of the 190 studies in Tobacco Use Cessation with a site in United States are open now. Recruiting first, the newest first:
University of Pennsylvania · Sites in United States
Ages 18+
University of Chicago · Sites in United States
Ages 18–26
University of California, San Francisco · Sites in United States
Ages 18+ · Women only · Healthy volunteers
University of California, San Francisco · Sites in United States
Ages 18+
University of Florida · Sites in United States
Ages 18+ · 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 23 Tobacco Use Cessation studies recruiting now, 16 (70%) set no upper age limit and 6 (26%) stop at 75 or younger; 1 takes children under 18; 9 take healthy volunteers.
This study: 18 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.
190 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 12 · Phase 2 20 · Phase 3 23 · Phase 4 14
First in 1984; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 31 is below the median of 226 across 256 interventional studies indexed under Tobacco Use Cessation.
Median enrollment 213 across the 184 interventional studies, 169 across the 6 observational. Of the 142 that completed or were terminated, 61 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 190 have an industry lead sponsor. The 10 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University has 7 studies filed under Tobacco Use Cessation — fewer than ten, so there is no comparison to draw.
21 of the studies in Tobacco Use Cessation 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 |
|---|---|
| NCT06837220University of ChicagoImplementation of Tobacco Cessation Programming at Community Behavioral Health Sites | 2026-12 |
| NCT05445804Johns Hopkins UniversityOral Cannabidiol for Tobacco Cessation | 2026-12-01 |
| NCT07129590University of California, San FranciscoTrauma-Informed Care for Smoking Cessation for Pregnancy | 2026-12-31 |
| NCT05868421VA Office of Research and DevelopmentVeteran Social Support for Enhancing Use of Smoking Cessation Treatment | 2027-02-01 |
| NCT07735286University of PennsylvaniaAutomating Tobacco Cessation in Primary Care | 2027-03-23 |
Add all 21 to your calendar (.ics) → With an account.
Among the 190 studies in Tobacco Use Cessation 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 pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention to promote smoking cessation among light smokers.
The three-arm randomized controlled trial compares Arm 1) standard smoking cessation plus support text messages, 2) enhanced cue exposure treatment (lab-based + interactive SMS texting) + D-cycloserine placebo, Arm 3)will include a combination of cognitive behavioral cessation counseling, enhanced cue exposure treatment (lab-based + interactive SMS texting) and a cognitive-enhancing drug - D-cycloserine. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an inperson follow-up visit.
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:
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Standard smoking cessation plus support text messages
Behavioral: Cognitive behavioral cessation counseling
enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
Behavioral: Cognitive behavioral cessation counseling · Behavioral: Counseling and placebo drug intervention
enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Behavioral: Cognitive behavioral cessation counseling · Drug: Counseling and active drug intervention
Standard smoking cessation plus support text messages
Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Number of Participants With Completion of at Least 2 Study Visits
Feasibility will be determined by number of participants that complete at least 2 study visits.
Time frame: Approximately 8 weeks
Number of Participants Who Rated the Intervention Acceptable
Acceptability will be determined by the number of patients rating the intervention usefulness in the experimental and control arms on a 7-point Likert scale, where 1=extremely useless and 7=extremely useful.
Time frame: Approximately 8 weeks
Number of Participants With Validated Cessation
Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention.
Time frame: 1 week post-intervention
| Milestone | Experimental: Cognitive Behavioral Cessation Counseling | Placebo Comparator: Counseling and Placebo Drug Intervention | Active Comparator: Counseling and Active Drug Intervention |
|---|---|---|---|
| Started | 13 | 12 | 6 |
| Completed | 13 | 11 | 1 |
| Not completed | 0 | 1 | 5 |
Feasibility will be determined by number of participants that complete at least 2 study visits.
| Participants | Experimental: Cue-based Treatment | Control: Standard Counseling | Active Comparator: Counseling and Active Drug Intervention |
|---|---|---|---|
| Number of Participants With Completion of at Least 2 Study Visits | 10 | 7 | 1 |
Acceptability will be determined by the number of patients rating the intervention usefulness in the experimental and control arms on a 7-point Likert scale, where 1=extremely useless and 7=extremely useful.
| Participants | Total |
|---|---|
| Number of Participants Who Rated the Intervention Acceptable | 23 |
Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention.
| Participants | Experimental: Cue-based Treatment | Control: Standard Counseling | Active Comparator: Counseling and Active Drug Intervention |
|---|---|---|---|
| Number of Participants With Validated Cessation | 2 | 0 | 0 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Cognitive Behavioral Cessation Counseling | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Placebo Comparator: Counseling and Placebo Drug Intervention | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Active Comparator: Counseling and Active Drug Intervention | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
In the comparator standard counseling, one enrolled patient withdrew prior to completing the baseline survey. Three participants in the active comparator arm did not complete the baseline survey.
| Age, Continuous(years) | Experimental: Cue-based Treatment | Comparator: Standard Counseling | Active Comparator: Counseling and Active Drug Intervention | Total |
|---|---|---|---|---|
| Mean | 42.3 ± 14.8 | 44.2 ± 18.4 | 43 ± 24 | 43.2 ± 16.2 |
| Sex: Female, Male(Participants) | Experimental: Cue-based Treatment | Comparator: Standard Counseling | Active Comparator: Counseling and Active Drug Intervention | Total |
|---|---|---|---|---|
| Female | 10 | 8 | 1 | 19 |
| Male | 3 | 3 | 2 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Experimental: Cue-based Treatment | Comparator: Standard Counseling | Active Comparator: Counseling and Active Drug Intervention | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 0 | 2 |
| Not Hispanic or Latino | 11 | 10 | 3 | 24 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Experimental: Cue-based Treatment | Comparator: Standard Counseling | Active Comparator: Counseling and Active Drug Intervention | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 8 | 7 | 2 | 17 |
| White | 3 | 4 | 1 | 8 |
| More than one race | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Education: Some college or college grad(Participants) | Experimental: Cue-based Treatment | Comparator: Standard Counseling | Active Comparator: Counseling and Active Drug Intervention | Total |
|---|---|---|---|---|
| Count of participants | 8 | 9 | 3 | 20 |
| Employment status: Employed(Participants) | Experimental: Cue-based Treatment | Comparator: Standard Counseling | Active Comparator: Counseling and Active Drug Intervention | Total |
|---|---|---|---|---|
| Count of participants | 3 | 5 | 2 | 10 |
| Type of smoker(Participants) | Experimental: Cue-based Treatment | Comparator: Standard Counseling | Active Comparator: Counseling and Active Drug Intervention | Total |
|---|---|---|---|---|
| Daily | 12 | 11 | 3 | 26 |
| Intermittent | 1 | 0 | 0 | 1 |
| Cigarettes per day(cigarettes per day) | Experimental: Cue-based Treatment | Comparator: Standard Counseling | Active Comparator: Counseling and Active Drug Intervention | Total |
|---|---|---|---|---|
| Mean | 5.8 ± 2.5 | 6.5 ± 2.0 | 7 ± 3.6 | 6.1 ± 2.2 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Feb 2020, 21 months.
Results were first posted in Feb 2021, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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