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NCT02193256 · ClinicalTrials.gov registry record · Early Phase 1
Varenicline + Prazosin for Heavy Drinking Smokers
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT02193256: Completed Early Phase 1 study, sponsored by Yale University.
NCT02193256 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02193256, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the effect of varenicline and prazosin on smoking, drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an FDA approved smoking cessation medication. Some smokers report sleep problems when taking varenicline. This study will test whether using prazosin, which is an FDA-approved blood pressure medication, in combination with varenicline reduces sleep problems that can be associated with using varenicline for smoking cessation. In addition, the study will examine the combined effects of these medications on smoking and drinking. Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone prior to the 3-day practice quit attempt. Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone during the 3-day practice quit attempt.
Primary Outcome
Sleep disturbance will be measured using self-report questionnaires (Insomnia Severity Index, Pittsburgh Sleep Quality Index, Pittsburgh Sleep Diary, Dream Quality Questionnaire) and objective sleep-monitoring devices.
Interventions
- DRUG Placebo
- DRUG Varenicline
- DRUG Prazosin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-06 |
| Phase | Early Phase 1 |
What the finished NCT02193256 record still lists
NCT02193256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02193256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02193256 about?
NCT02193256 is a clinical study titled "Varenicline + Prazosin for Heavy Drinking Smokers". The purpose of this study is to examine the effect of varenicline and prazosin on smoking, drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an FDA approved smoking cessation medication. Some smokers report sleep problems when taking varenicline. This study wil...
What is the current status of trial NCT02193256?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2014-07. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02193256?
The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG), Prazosin (DRUG).
Who is sponsoring clinical trial NCT02193256?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02193256's enrollment target sits among peer trials
5 1888th of 2000 higher than 80 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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