NCT00120601

Trial for the Treatment of Alcohol Dependence

The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Naltrexone
DRUG	Acamprosate

Timeline

• Start date: 2003-03-01
• Completion: 2005-06-01
• First posted: 2005-07-18
• Last updated: 2005-07-18

Locations

1 site across 1 country: Australia