Trial for the Treatment of Alcohol Dependence

Alcoholism Clinical Trial

Official title:

The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00120601
• Other study ID #: X99-0277
• Secondary ID: 211177
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 11, 2005
• Last updated: July 15, 2005
• Start date: March 2003
• Est. completion date: June 2005

Study information

• Verified date: June 2005
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Naltrexone

• Acamprosate

Locations

Country	Name	City	State
Australia	Drug Health Services, Royal Prince Alfred Hospital	Sydney	New South Wales

Sponsors (5)

Lead Sponsor	Collaborator
University of Sydney	National Health and Medical Research Council, Australia, South Eastern Area Health Service, Sydney South West Area Health Service, Wentworth Area Health Services

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (days) to relapse
Primary	Time (days) to lapse
Primary	Days abstinence
Primary	Drinks per drinking day
Primary	Biochemical measures of liver function
Secondary	Craving
Secondary	Depression
Secondary	Anxiety
Secondary	Stress
Secondary	Global physical health
Secondary	Global mental health

External Links

•   Click here for more information about this study: The Alcohol Pharmacotherapy Project. This study is run through the University of Sydney.