Alcohol Dependence Clinical Trial
Official title:
Phase Four Randomized, Multicentre, Open-Label, Comparative Trial Of Disulfiram, Nalterexone And Acamprosate In The Treatment Of Alcohol Dependence
The aim of this study was to compare the effect of manual based cognitive therapy in adjunct of three different pharmacotherapy.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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