Trial for the Treatment of Alcohol Dependence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Alcoholism

Keywords

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treatment alcohol dependence medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Naltrexone

Intervention Type DRUG

Acamprosate

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Paul Haber, MBBAMDFRACP

Role: STUDY_CHAIR

Conjoint Associate Professor

Locations

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Drug Health Services, Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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211177

Identifier Type: -

Identifier Source: secondary_id

X99-0277