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

Condition	Intervention	Phase
Alcoholism	Drug: Naltrexone  Drug: Acamprosate	Phase IV

Further Study Details: 

Primary Outcomes: Time (days) to relapse; Time (days) to lapse; Days abstinence; Drinks per drinking day; Biochemical measures of liver function
Secondary Outcomes: Craving; Depression; Anxiety; Stress; Global physical health; Global mental health
Expected Total Enrollment:  200

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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)

Australia, New South Wales
      Drug Health Services, Royal Prince Alfred Hospital, Sydney,  New South Wales,  2050,  Australia

Study chairs or principal investigators

Paul Haber, MBBAMDFRACP,  Study Chair,  Conjoint Associate Professor   

Study ID Numbers:  X99-0277; 211177
Last Updated:  July 18, 2005
Record first received:  July 15, 2005
ClinicalTrials.gov Identifier:  NCT00120601
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-08-02