Trial for the Treatment of Alcohol Dependence

• Status: Unknown status
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sydney
• Collaborators: National Health and Medical Research Council, Australia; South Eastern Area Health Service; Sydney South West Area Health Service; Wentworth Area Health Services
• Treatments: Acamprosate; Ethanol; Naltrexone

Criteria

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)