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Gabapentin for Abstinence Initiation in Alcohol Dependence
NCT01141049 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01141049
The ClinicalTrials.gov registry entry for NCT01141049 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01141049 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01141049?
The interventions under investigation include: Placebo (OTHER), Gabapentin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01141049?
This trial is sponsored by New York State Psychiatric Institute, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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