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Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients

NCT01738282 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2014-07-30

No results posted yet for this study

Summary

The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions.

Conditions

  • Alcohol Dependence

Interventions

DRUG

Baclofen

DRUG

Placebo (for baclofen)

Sponsors & Collaborators

  • Ethypharm

    lead INDUSTRY

Principal Investigators

  • Michel REYNAUD, MD · Villejuif, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01738282 on ClinicalTrials.gov