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
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • Time (days) to relapse
  • Time (days) to lapse
  • Days abstinence
  • Drinks per drinking day
  • Biochemical measures of liver function

Secondary Outcome Measures:
  • Craving
  • Depression
  • Anxiety
  • Stress
  • Global physical health
  • Global mental health

Estimated Enrollment: 200
Study Start Date: March 2003
Estimated Study Completion Date: June 2005
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120601

Locations
Australia, New South Wales
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Sponsors and Collaborators
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
Investigators
Study Chair: Paul Haber, MBBAMDFRACP Conjoint Associate Professor
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00120601     History of Changes
Other Study ID Numbers: X99-0277, 211177
Study First Received: July 11, 2005
Last Updated: July 15, 2005
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Sydney:
treatment
alcohol
dependence
medication

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 23, 2014