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NCT01141049 · ClinicalTrials.gov registry record · Phase 2
Gabapentin for Abstinence Initiation in Alcohol Dependence
A Phase 2 study of Alcohol Dependence, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT01141049: Completed Phase 2 study of Alcohol Dependence, sponsored by New York State Psychiatric Institute.
NCT01141049 is a Phase 2 study of Alcohol Dependence that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 40 participants, below the 313-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01141049, a Phase 2 study of Alcohol Dependence, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
Primary Hypotheses: 1\. Gabapentin will significantly reduce alcohol consumption and promote abstinence as compared to placebo. The primary outcome measure will be the number of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline follow-back method. Secondary Hypotheses: 1\. Gabapentin will be superior to placebo in reducing alcohol use as measured by percent days abstinent.
Primary Outcome
percent of heavy drinking days as defined as 5 drinks per day for males and 4 drinks per day for females over the course of a study week.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Gabapentin
Study Locations (2)
New York
- Substance Treatment and Research Service (STARS) - New York
- New York State Psychiatric Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT01141049 record still lists
NCT01141049 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 313-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Alcohol Dependence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01141049 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01141049 about?
NCT01141049 is a clinical study titled "Gabapentin for Abstinence Initiation in Alcohol Dependence". Primary Hypotheses: 1\. Gabapentin will significantly reduce alcohol consumption and promote abstinence as compared to placebo. The primary outcome measure will be the number of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for...
What is the current status of trial NCT01141049?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2010-08. Estimated completion is 2012-12.
What conditions does trial NCT01141049 study?
This clinical trial studies the following conditions: Alcohol Dependence.
What interventions are being tested in trial NCT01141049?
The interventions under investigation include: Placebo (OTHER), Gabapentin (DRUG).
Who is sponsoring clinical trial NCT01141049?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01141049 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Dependence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01141049's enrollment target sits among peer trials
40 34th of 43 higher than 9 of 43 other Alcohol Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Dependence 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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