Integrative Therapy in Alcoholism

Phase 4

Completed

• Conditions: Alcoholism
• Interventions: Drug: Acamprosate; Behavioral: Integrative behavior therapy; Drug: Placebo

• Registration Number: NCT00159107
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

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 Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2006-12
• Status Verified: 2007-10
• Last Update Submitted: 2008-01-29
• Last Update Posted: 2008-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Acamprosate	Acamprosate + treatment as usual
1	Acamprosate	Acamprosate + Integrative behavior therapy
1	Integrative behavior therapy	Acamprosate + Integrative behavior therapy
2	Integrative behavior therapy	Placebo +Integrative behavior therapy
2	Placebo	Placebo +Integrative behavior therapy

Primary Outcome Measures

Name	Time	Method
Abstinence	3,6,12 months

Secondary Outcome Measures

Name	Time	Method
Social functioning	12 months
Cognitive functioning	12 months

Trial Locations

Locations (1)

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