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NCT01989507 · ClinicalTrials.gov registry record · Phase 2
Very Low-Nicotine Cigarettes in Smokers With SUD
A Phase 2 study, sponsored by Brown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT01989507: Completed Phase 2 study, sponsored by Brown University.
NCT01989507 is a Phase 2 study that has completed, run by Brown University. The registered enrollment target is 250 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01989507, a Phase 2 study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy, acceptability and unintended consequences of very low nicotine content cigarettes (VLNCC) in smokers with current or past year substance use disorders (SUD). The primary aim of this study is to determine whether 6 weeks of VLNCC compared to normal nicotine content cigarettes (NNCC) will result in more smoking cessation over 6 months and reduce cigarette use, cotinine, and biomarkers of toxicity. We will also assess the effects of VLNCC versus NNCC cigarettes on frequency of substance use and substance cravings (drugs and alcohol) because this is relevant to the safety of these products among smokers with SUD. Secondary aims are to study effects on cigarette craving, nicotine withdrawal and dependence, and depressed mood. Methods: Random assignment to VLNCC versus NNCC of up to 312 smokers with SUD will be balanced by gender, degree of tobacco dependence, and recent drug and alcohol use. All smokers will be provided with smoking counseling. Assessments over 6 months will assess effects both during the 6 weeks of using research cigarettes and after return to usual cigarettes. The importance is in determining the viability and safety of this public health strategy in terms of effects on both smoking and other substance use in a highly addicted population, which is essential to determine before the FDA implements this policy.
Primary Outcome
self-report of past 7 days abstinence confirmed by expired carbon monoxide (CO) reading of 6 ppm or less
Interventions
- DRUG Nicotine
- BEHAVIORAL behavioral counseling for smoking cessation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2014-04 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 2 |
What the finished NCT01989507 record still lists
NCT01989507 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 2 interventions - of which Nicotine is the first listed.
NCT01989507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01989507 about?
NCT01989507 is a clinical study titled "Very Low-Nicotine Cigarettes in Smokers With SUD". The purpose of this study is to determine the efficacy, acceptability and unintended consequences of very low nicotine content cigarettes (VLNCC) in smokers with current or past year substance use disorders (SUD). The primary aim of this study is to determine whether 6 weeks of VLNCC compared to nor...
What is the current status of trial NCT01989507?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2014-04. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT01989507?
The interventions under investigation include: Nicotine (DRUG), behavioral counseling for smoking cessation (BEHAVIORAL).
Who is sponsoring clinical trial NCT01989507?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01989507's enrollment target sits among peer trials
250 222nd of 2000 higher than 1,768 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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