Integrative Therapy in Alcoholism

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159107
• Other study ID #: 01EB0133
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: January 29, 2008
• Start date: May 2003
• Est. completion date: December 2006

Study information

• Verified date: October 2007
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Acamprosate
Acamprosate

Behavioral:
• Integrative behavior therapy
Integrative behavior therapy

Drug:
• Placebo
Placebo

Locations

Country	Name	City	State
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

Sponsors (8)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	German Addiction Research Network, German Federal Ministry of Education and Research, Merck Sharp & Dohme Corp., Psychosomatic Clinic of Bergisch Gladbach, Universität Duisburg-Essen, University of Bonn, University of Homburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence		3,6,12 months
Secondary	Social functioning		12 months
Secondary	Cognitive functioning		12 months