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Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study.

NCT00614328 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-05-06

No results posted yet for this study

Summary

The purpose of this research study is to learn about the use of a combination of two medications, baclofen and naltrexone, for the treatment of alcohol dependence in men and women ages 25-60 years old. Naltrexone is an FDA approved medication for treatment of alcohol dependence. The most widely accepted idea for naltrexone's effect is that it reduces the alcohol "high", which decreases a desire to consume alcohol. As a result, alcoholic patients treated with naltrexone are less likely to relapse to heavy drinking. Furthermore, naltrexone treated patients drink fewer days and are more likely to maintain abstinence.

However, naltrexone does not have any effect on other symptoms that may contribute to relapse such as anxiety, sleep problems and irritability. Baclofen, an FDA approved medication for muscle spasms, may improve some of these symptoms.

Therefore, the purpose of the current study is to gather information on whether adding baclofen to naltrexone is feasible and well tolerated.

Conditions

  • Alcohol Dependence

Interventions

DRUG

Naltrexone, Baclofen, Placebo and Behavior Therapy

Naltrexone 50mg/day for 12 weeks Baclofen 10mg tid = 30mg/day for 12 weeks Behavior Therapy 9 sessions

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • James C Garbutt, M.D. · UNC-Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-01-31
Completion
2010-01-31

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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 NCT00614328 on ClinicalTrials.gov