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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Mental Disorders
Acamprosate
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014