Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence

Phase 4

Completed

• Conditions: Alcohol Dependence

• Registration Number: NCT00435435
• Lead Sponsor: Finnish Institute for Health and Welfare

Brief Summary

The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.

Detailed Description

Context Alcoholism is common clinical problem and its treatment has no standard and is controversy. Different pharmacotherapy's, acamporsate, nalterxone and disulfiram have shown to improve the drinking outcomes, but there is no randomized comparative studies on the effects of these three medications.

Objectives The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.

Design and setting Randomized, open label, multicentre naturalistic study, 12 week continuous medication followed by targeted medication up to 52weeks and 67 week follow up on voluntary treatment seeking alcohol dependent outpatients.

Participants 243 alcohol dependent adults. Intervention Subjects were randomized 1:1:1 to receive naltrexone, acamprosate or disulfiram, 50 mg, 1998 mg or 200 mg correspondingly per day. The patients were met weekly in first month, then after 3, 6 and 12 months.

Study Timeline

• Status Verified: 2000-02
• Study Start: 2000-09
• Study Completion: 2005-04
• Study First Submitted: 2007-02-14
• Study First Submitted QC: 2007-02-14
• Study First Posted: 2007-02-15
• Last Update Submitted: 2007-02-15
• Last Update Posted: 2007-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• Alcohol dependence (ICD-10)

Exclusion Criteria

• Clinically significant symptoms of alcohol withdrawal
• Significant recently diagnosed psychiatric disease (psychosis, personality disorder or suicidal tendency that appeared during the initial interview)
• Current psychiatric disease demanding special treatment or medication including DSM-IV determined drug dependence other than alcohol or nicotine dependence
• Current use of any opioids within four weeks before screening
• Significant brain, thyroid, kidney, uncompensated heart disease, or clinically significant liver disease (cirrhosis, aqlcoholic hepatitis or ALAT > 200)
• Pregnancy, nursing, or women refused to use a reliable method for birth control

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time(days) to first heavy drinking (HDD)day after medication started

Secondary Outcome Measures

Name	Time	Method
Time (days) to first drinking after medication started
Abstinence days (0 drinks/ day) by group
Average alcohol intake (weekly by group)
ALAT
GGT
SADD
AUDIT
EQ-5

Trial Locations

Locations (1)

National Public Health Institute, Department of Mental Health and Alcohol Research; 🇫🇮 Helsinki, Finland