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Trial for the Treatment of Alcohol Dependence

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by University of Sydney.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00120601
First Posted: July 18, 2005
Last Update Posted: December 9, 2005
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.
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
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00120601     History of Changes
Other Study ID Numbers: X99-0277
211177
First Submitted: July 11, 2005
First Posted: July 18, 2005
Last Update Posted: December 9, 2005
Last Verified: June 2005

Keywords provided by University of Sydney:
treatment
alcohol
dependence
medication

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Naltrexone
Acamprosate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents