NCT00435435

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

Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 243 (planned)
• Sponsor: Finnish Institute for Health and Welfare · Other Government
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Disulfiram
DRUG	Acamprosate
DRUG	Naltexone

Timeline

• Start date: 2000-09-01
• Completion: 2005-04-01
• First posted: 2007-02-15
• Last updated: 2007-02-16

Locations

1 site across 1 country: Finland