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NCT01613014 · ClinicalTrials.gov registry record · Phase 2
ABT-436 for Alcohol Dependence
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT01613014: Completed Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT01613014 is a Phase 2 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01613014, a Phase 2 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
The primary efficacy endpoint examines the hypothesis that ABT-436 will decrease the weekly percentage of heavy drinking days during Study Weeks 2 through 12 (Days 8-84) as compared to placebo. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Primary Outcome
The primary objective of this study is to assess the efficacy of ABT-436 to reduce the weekly percentage of heavy drinking days (reduction in drinking) in subjects with alcohol dependence confirmed by DSM-IV-TR criteria. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men. The outcome measure was averaged across weeks 2-12.
Interventions
- DRUG ABT-436
- DRUG Matched Placebo - Sugar Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-02 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01613014 record still lists
NCT01613014 is an interventional study that assigns participants to a tested intervention. The registered 150 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 (13% higher).
The record links to 0 conditions, and to 2 interventions - of which ABT-436 is the first listed.
NCT01613014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01613014 about?
NCT01613014 is a clinical study titled "ABT-436 for Alcohol Dependence". The primary efficacy endpoint examines the hypothesis that ABT-436 will decrease the weekly percentage of heavy drinking days during Study Weeks 2 through 12 (Days 8-84) as compared to placebo. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking da...
What is the current status of trial NCT01613014?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2013-02. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01613014?
The interventions under investigation include: ABT-436 (DRUG), Matched Placebo - Sugar Pill (DRUG).
Who is sponsoring clinical trial NCT01613014?
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 NCT01613014's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 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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