Trial for the Treatment of Alcohol Dependence

University of Sydney

Status and phase

Unknown

Phase 4

Conditions

Alcoholism

Treatments

Drug: Naltrexone

Drug: Acamprosate

Study type

Interventional

Funder types

Other

Identifiers

NCT00120601

X99-0277

211177

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)