Alcoholism
Conditions
Keywords
treatment, alcohol, dependence, medication
Brief summary
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
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.
Interventions
DRUGNaltrexone
DRUGAcamprosate
Sponsors
National Health and Medical Research Council, Australia
Sydney South West Area Health Service
South Eastern Area Health Service
Wentworth Area Health Services
University of Sydney
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (days) to relapse | — |
| Time (days) to lapse | — |
| Days abstinence | — |
| Drinks per drinking day | — |
| Biochemical measures of liver function | — |
Secondary
| Measure | Time frame |
|---|---|
| Craving | — |
| Global mental health | — |
| Depression | — |
| Anxiety | — |
| Stress | — |
| Global physical health | — |
Countries
Australia
Outcome results
None listed