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Clinical Trial Summary

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


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00435435
Study type Interventional
Source National Institute for Health and Welfare, Finland
Contact
Status Completed
Phase Phase 4
Start date September 2000
Completion date April 2005

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