Integrative Therapy in Alcoholism

January 29, 2008 updated by: Heinrich-Heine University, Duesseldorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

371

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westfalia
      • Düsseldorf, North Rhine-Westfalia, Germany, 40629
        • Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstrasse 2, 40629 Düsseldorf, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Placebo +Integrative behavior therapy
Drug: Placebo
Placebo
Behavioral: Integrative behavior therapy
Integrative behavior therapy
Experimental: 3
Acamprosate + treatment as usual
Drug: Acamprosate
Acamprosate
Experimental: 1
Acamprosate + Integrative behavior therapy
Behavioral: Integrative behavior therapy
Integrative behavior therapy
Drug: Acamprosate
Acamprosate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abstinence
Time Frame: 3,6,12 months
3,6,12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Social functioning
Time Frame: 12 months
12 months
Cognitive functioning
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

Merck Sharp & Dohme LLC
German Federal Ministry of Education and Research
Universität Duisburg-Essen
University of Bonn
University of Homburg
German Addiction Research Network
Psychosomatic Clinic of Bergisch Gladbach

Investigators

  • Study Chair: Wolfgang Gaebel, Professor, Department of Psychiatry and Psychotherapy, University of Düsseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 30, 2008

Last Update Submitted That Met QC Criteria

January 29, 2008

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01EB0133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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