This trial is active, not recruiting.

Condition alcoholism
Treatments naltrexone, acamprosate
Phase phase 4
Sponsor University of Sydney
Collaborator National Health and Medical Research Council, Australia
Start date March 2003
End date June 2005
Trial size 200 participants
Trial identifier NCT00120601, 211177, X99-0277


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Time (days) to relapse
time frame:
Time (days) to lapse
time frame:
Days abstinence
time frame:
Drinks per drinking day
time frame:
Biochemical measures of liver function
time frame:

Secondary Outcomes

time frame:
time frame:
time frame:
time frame:
Global physical health
time frame:
Global mental health
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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)

Additional Information

Official title The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2005.
Information provided to ClinicalTrials.gov by University of Sydney.