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Integrative Therapy in Alcoholism

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ClinicalTrials.gov Identifier: NCT00159107
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 30, 2008
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Acamprosate Behavioral: Integrative behavior therapy Drug: Placebo Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acamprosate and Integrative Behavior Therapy in the Outpatient Treatment of Alcohol Dependents
Study Start Date : May 2003
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Abstinence [ Time Frame: 3,6,12 months ]

Secondary Outcome Measures :
  1. Social functioning [ Time Frame: 12 months ]
  2. Cognitive functioning [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159107

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, 40629
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
German Federal Ministry of Education and Research
German Addiction Research Network
Merck Sharp & Dohme Corp.
University of Bonn
Universität Duisburg-Essen
University of Homburg
Psychosomatic Clinic of Bergisch Gladbach
Study Chair: Wolfgang Gaebel, Professor Department of Psychiatry and Psychotherapy, University of Düsseldorf
More Information

ClinicalTrials.gov Identifier: NCT00159107     History of Changes
Other Study ID Numbers: 01EB0133
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: October 2007

Keywords provided by Heinrich-Heine University, Duesseldorf:
abstinence enhancement
cognitive behavior therapy vs. supportive counseling
Acamprosate vs. Placebo
multi-center study

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents