Integrative Therapy in Alcoholism

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Addiction Research Network
Merck Santé
University of Bonn
Universität Duisburg-Essen
University of Homburg
Psychosomatic Clinic of Bergisch Gladbach
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00159107
First received: September 7, 2005
Last updated: January 29, 2008
Last verified: October 2007
  Purpose

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 Intervention Phase
Alcoholism
Drug: Acamprosate
Behavioral: Integrative behavior therapy
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acamprosate and Integrative Behavior Therapy in the Outpatient Treatment of Alcohol Dependents

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

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

Secondary Outcome Measures:
  • Social functioning [ Time Frame: 12 months ]
  • Cognitive functioning [ Time Frame: 12 months ]

Enrollment: 371
Study Start Date: May 2003
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: 2
Placebo +Integrative behavior therapy
Behavioral: Integrative behavior therapy
Integrative behavior therapy
Drug: Placebo
Placebo
Experimental: 3
Acamprosate + treatment as usual
Drug: Acamprosate
Acamprosate
Experimental: 1
Acamprosate + Integrative behavior therapy
Drug: Acamprosate
Acamprosate
Behavioral: Integrative behavior therapy
Integrative behavior therapy

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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159107

Locations
Germany
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 Santé
University of Bonn
Universität Duisburg-Essen
University of Homburg
Psychosomatic Clinic of Bergisch Gladbach
Investigators
Study Chair: Wolfgang Gaebel, Professor Department of Psychiatry and Psychotherapy, University of Düsseldorf
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00159107     History of Changes
Other Study ID Numbers: 01EB0133
Study First Received: September 7, 2005
Last Updated: January 29, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Acamprosate
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014