Trial for the Treatment of Alcohol Dependence

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by University of Sydney.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00120601
First received: July 11, 2005
Last updated: July 15, 2005
Last verified: June 2005

July 11, 2005
July 15, 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
Complete list of historical versions of study NCT00120601 on ClinicalTrials.gov Archive Site
  • 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alcoholism
  • Drug: Naltrexone
  • Drug: Acamprosate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00120601
X99-0277, 211177
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