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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2005-04-30

Brief Summary

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

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Detailed Description

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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

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Disulfiram

Intervention Type DRUG

Acamprosate

Intervention Type DRUG

Naltexone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes