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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 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.

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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.

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

FieldValue
Enrollment Target 40 participants
Start Date 2010-08
Est. Completion 2012-12
Phase Phase 2

What the Registry Record Tells You About NCT01141049

The ClinicalTrials.gov registry entry for NCT01141049 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 313-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (87% lower). The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.