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NCT01076283 · ClinicalTrials.gov registry record · Phase 2

A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking

A Phase 2 study, sponsored by Brown University.

Completed
Registry status
Phase 2
Development phase
14
Enrollment target

NCT01076283: Completed Phase 2 study, sponsored by Brown University.

NCT01076283 is a Phase 2 study that has completed, run by Brown University. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01076283, a Phase 2 study, has completed, sponsored by Brown University.

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target

Study Summary

This pilot trial has the goal to demonstrate the feasibility of a study to test the effects of baclofen in a laboratory experiment using cue-reactivity and alcohol-self administration paradigms in non-treatment seeking alcohol-dependent subjects.

Primary Outcome

Whether baclofen, as compared to active placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink \[as measured by the Alcohol Urge Questionnaire (AUQ)\] during the Cue Reactivity. The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Like

Interventions

  • DRUG Cyproheptadine
  • DRUG Baclofen

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2009-12
Est. Completion 2010-05
Phase Phase 2
Brown University

231 total trials

What the finished NCT01076283 record still lists

NCT01076283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Cyproheptadine is the first listed.

NCT01076283 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01076283 about?

NCT01076283 is a clinical study titled "A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking". This pilot trial has the goal to demonstrate the feasibility of a study to test the effects of baclofen in a laboratory experiment using cue-reactivity and alcohol-self administration paradigms in non-treatment seeking alcohol-dependent subjects.

What is the current status of trial NCT01076283?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2009-12. Estimated completion is 2010-05.

What interventions are being tested in trial NCT01076283?

The interventions under investigation include: Cyproheptadine (DRUG), Baclofen (DRUG).

Who is sponsoring clinical trial NCT01076283?

This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01076283's enrollment target sits among peer trials

14 1941st of 2000 higher than 54 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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Source: ClinicalTrials.gov NCT01076283, the US trial registry maintained by the National Library of Medicine. NCT01076283 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.