Clinical trial NCT00120601: Trial for the Treatment of Alcohol Dependence
Official title: The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alcoholism
Keywords: treatment
alcohol
dependence
medication
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: Sydney South West Area Health Service
name: South Eastern Area Health Service
name: Wentworth Area Health Services
First posted: 2005-07-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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)

Primary outcomes:
measure: Time (days) to relapse
measure: Time (days) to lapse
measure: Days abstinence
measure: Drinks per drinking day
measure: Biochemical measures of liver function
Secondary outcomes:
measure: Craving
measure: Depression
measure: Anxiety
measure: Stress
measure: Global physical health
measure: Global mental health
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Drug Health Services, Royal Prince Alfred Hospital
state: New South Wales
Study officials:
affiliation: Conjoint Associate Professor
name: Paul Haber, MBBAMDFRACP
role: STUDY_CHAIR
References: