Trial for the Treatment of Alcohol Dependence

July 15, 2005 updated by: University of Sydney

The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence

The purpose of this study is to compare the effectiveness of two anti-craving medications, naltrexone versus acamprosate, in the treatment of alcohol dependence.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The physical, psychological and social consequences of alcohol abuse remain a critical health problem. Every year in Australia, excessive consumption is responsible for 3,000 - 6,000 deaths and costs the community $6 billion. Approximately 15% of Australians abuse alcohol and 5% of men and 3% of women are alcohol dependent (addicted to alcohol). Better treatment for alcohol dependence is urgently needed. Treatment for alcohol dependence remains unsatisfactory. Most treatments lead to abstinence in only 1 out of 3 cases, and approximately 50% of these will relapse within 3 months of completing treatment. Two drugs (naltrexone and acamprosate) appear to interfere with the effects of alcohol on the brain that promote addiction. There is evidence that both drugs are beneficial in the treatment of alcohol dependence and both are now available in Australia. At present, no data have been reported comparing the effectiveness of these two drugs. The proposed project will compare naltrexone and acamprosate in a large, carefully performed, study. The study will help determine which subjects are likely to benefit from one or the other of these agents.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Drug Health Services, Royal Prince Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Alcohol dependence according to the ICD10 criteria, with alcohol as the subject's drug of choice
  • Ages 18-65
  • Adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by MMSE)
  • Willingness to give written informed consent
  • Abstinence from alcohol for between 3 and 21 days, and resolution of any clinically evident alcohol withdrawal

Exclusion Criteria:

  • Opiate abuse within the last one month
  • Sensitivity to study medications or therapy with these drugs within 6 months
  • Active major psychiatric disorder associated with psychosis or significant suicide risk
  • Pregnancy or lactation
  • Advanced decompensated liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time (days) to relapse
Time (days) to lapse
Days abstinence
Drinks per drinking day
Biochemical measures of liver function

Secondary Outcome Measures

Outcome Measure
Depression
Anxiety
Craving
Stress
Global physical health
Global mental health

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sydney

Collaborators

National Health and Medical Research Council, Australia
Sydney South West Area Health Service
South Eastern Area Health Service
Wentworth Area Health Services

Investigators

  • Study Chair: Paul Haber, MBBAMDFRACP, Conjoint Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

July 11, 2005

First Submitted That Met QC Criteria

July 15, 2005

First Posted (Estimate)

July 18, 2005

Study Record Updates

Last Update Posted (Estimate)

July 18, 2005

Last Update Submitted That Met QC Criteria

July 15, 2005

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X99-0277
  • 211177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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