Trial for the Treatment of Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120601
Recruitment Status : Unknown
Verified June 2005 by University of Sydney.
Recruitment status was:  Active, not recruiting
First Posted : July 18, 2005
Last Update Posted : July 18, 2005
National Health and Medical Research Council, Australia
Sydney South West Area Health Service
South Eastern Area Health Service
Wentworth Area Health Services
Information provided by:
University of Sydney

July 11, 2005
July 18, 2005
July 18, 2005
March 2003
Not Provided
  • Time (days) to relapse
  • Time (days) to lapse
  • Days abstinence
  • Drinks per drinking day
  • Biochemical measures of liver function
Same as current
No Changes Posted
  • Craving
  • Depression
  • Anxiety
  • Stress
  • Global physical health
  • Global mental health
Same as current
Not Provided
Not Provided
Trial for the Treatment of Alcohol Dependence
The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence
The purpose of this study is to compare the effectiveness of two anti-craving medications, naltrexone versus acamprosate, in the treatment of alcohol dependence.
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Drug: Naltrexone
  • Drug: Acamprosate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2005
Not Provided

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
University of Sydney
  • National Health and Medical Research Council, Australia
  • Sydney South West Area Health Service
  • South Eastern Area Health Service
  • Wentworth Area Health Services
Study Chair: Paul Haber, MBBAMDFRACP Conjoint Associate Professor
University of Sydney
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP