Trial for the Treatment of Alcohol Dependence

Study Overview
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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.

Official Title
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The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Acamprosate


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Naltrexone|nan|
|Drug: Acamprosate|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  |  | 
| Depression |  |  | 
| Anxiety |  |  | 
| Stress |  |  | 
| Global physical health |  |  | 
| Global mental health |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment, alcohol, dependence, medication