Integrative Therapy in Alcoholism

Study Overview
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Brief Summary
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The main aim of this project consists in the investigation of the interaction of behavior therapy and Acamprosate in the outpatient treatment of alcoholic patients in a randomized, prospective and (regarding study medication Acamprosate vs. Placebo) double blind design. A total of 371 patients has been randomly assigned immediately after detoxification to one of three different outpatient treat-ment conditions.

Detailed Description
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The objective of this multi-center study is to optimize the long-term treatment of patients with alcohol dependence. This investigation should contribute to the issue of effective relapse prevention. Each treatment condition is lasting 6 months: a) Behavior Group Therapy + Acamprosate, b) Behavior Group Therapy + Placebo and c) support and counseling + Acamprosate. Follow-up examinations carried out 3 and 6 months after the end of treatment.

Official Title
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Acamprosate and Integrative Behavior Therapy in the Outpatient Treatment of Alcohol Dependents

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: Acamprosate
* Behavioral: Integrative behavior therapy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSMIV criteria of alcoholism Age between 25 and 60 Informed consent Exclusion Criteria: Residence outside of the catchment area Legal reasons Insufficient knowledge of the German language Substance abuse or addiction other than alcohol or nicotine Pregnancy Serious physical illness Organic brain disease Contraindication to Acamprosate treatment

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Placebo +Integrative behavior therapy | Behavioral: Integrative behavior therapy<br>* Integrative behavior therapy<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: 3<br>Acamprosate + treatment as usual | Drug: Acamprosate<br>* Acamprosate<br>|
| Experimental: 1<br>Acamprosate + Integrative behavior therapy | Drug: Acamprosate<br>* Acamprosate<br>Behavioral: Integrative behavior therapy<br>* Integrative behavior therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence |  | 3,6,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social functioning |  | 12 months | 
| Cognitive functioning |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcoholism, abstinence enhancement, psychotherapy, cognitive behavior therapy vs. supportive counseling, Acamprosate vs. Placebo, multi-center study