Status:
UNKNOWN
Trial for the Treatment of Alcohol Dependence
Lead Sponsor:
University of Sydney
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Sydney South West Area Health Service
Conditions:
Alcoholism
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00120601
Start Date
March 1 2003
End Date
June 1 2005
Last Update
July 18 2005
Active Locations (1)
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1
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050