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NCT01146613 · ClinicalTrials.gov registry record · Phase 2
Varenicline for Alcohol Dependence
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT01146613: Completed Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT01146613 is a Phase 2 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01146613, a Phase 2 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).
Primary Outcome
Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.
Interventions
- DRUG Placebo
- DRUG Varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT01146613 record still lists
NCT01146613 is an interventional study that assigns participants to a tested intervention. The registered 200 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 (50% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01146613 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01146613 about?
NCT01146613 is a clinical study titled "Varenicline for Alcohol Dependence". The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) crit...
What is the current status of trial NCT01146613?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2011-02. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01146613?
The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG).
Who is sponsoring clinical trial NCT01146613?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01146613's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 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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