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Integrative Therapy in Alcoholism

NCT ID: NCT00159107

Last Updated: 2008-01-30

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

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-12-31

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.

Conditions

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Alcoholism

Keywords

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alcoholism abstinence enhancement psychotherapy cognitive behavior therapy vs. supportive counseling Acamprosate vs. Placebo multi-center study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

Placebo +Integrative behavior therapy

Group Type EXPERIMENTAL

Integrative behavior therapy

Intervention Type BEHAVIORAL

Integrative behavior therapy

Placebo

Intervention Type DRUG

Placebo

3

Acamprosate + treatment as usual

Group Type EXPERIMENTAL

Acamprosate

Intervention Type DRUG

Acamprosate

1

Acamprosate + Integrative behavior therapy

Group Type EXPERIMENTAL

Acamprosate

Intervention Type DRUG

Acamprosate

Integrative behavior therapy

Intervention Type BEHAVIORAL

Integrative behavior therapy

Interventions

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Acamprosate

Acamprosate

Intervention Type DRUG

Integrative behavior therapy

Integrative behavior therapy

Intervention Type BEHAVIORAL

Placebo

Placebo

Intervention Type DRUG

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

German Addiction Research Network

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Bonn

OTHER

Sponsor Role collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role collaborator

University of Homburg

OTHER

Sponsor Role collaborator

Psychosomatic Clinic of Bergisch Gladbach

UNKNOWN

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Principal Investigators

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Wolfgang Gaebel, Professor

Role: STUDY_CHAIR

Department of Psychiatry and Psychotherapy, University of Düsseldorf

Locations

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Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany

Düsseldorf, North Rhine-Westfalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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01EB0133

Identifier Type: -

Identifier Source: org_study_id