CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Baclofen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01980706
NCT01980706Phase 2Completed
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Efficacy and Safety of High Dose Baclofen for Alcohol Dependence

University of North Carolina, Chapel Hill·interventional·Posted Nov 11, 2013·Updated Jun 12, 2019

In Brief

A Phase 2 clinical trial evaluating Baclofen and Placebo for Alcoholism. Completed, enrolled 120 participants across 1 site.

Detailed Summary

The proposed study will carefully test the hypothesis that a robust dose of baclofen (90 mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day, predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety effects of baclofen within an alcohol dependent population and ascertain whether baseline levels of anxiety predict response to baclofen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 11, 2013
Enrollment StartDec 12, 2013
Primary CompletionOct 26, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 12.6 years ago

Interventions

Baclofendrug

Baclofen is a GABA-B agonist

Placebodrug

Pill containing no pharmacologically active substance.