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

Study Overview
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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.

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.

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

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: Disulfiram
* Drug: Acamprosate
* Drug: Naltexone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Disulfiram|nan|
|Drug: Acamprosate|nan|
|Drug: Naltexone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time(days) to first heavy drinking (HDD)day after medication started |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcoholism, Dependence, Randomization, Effect, Disulfiram, Naltrexone, Acamprosate