Integrative Therapy in Alcoholism

Heinrich-Heine University, Duesseldorf

Status and phase: Completed; Phase 4

Conditions: Alcoholism

Treatments: Drug: Placebo; Drug: Acamprosate; Behavioral: Integrative behavior therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00159107

01EB0133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 371 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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371 participants in 3 patient groups

2

Experimental group

Description:

Placebo +Integrative behavior therapy

Treatment:

Behavioral: Integrative behavior therapy

Drug: Placebo

3

Experimental group

Description:

Acamprosate + treatment as usual

Treatment:

Drug: Acamprosate

1

Experimental group

Description:

Acamprosate + Integrative behavior therapy

Treatment:

Drug: Acamprosate

Behavioral: Integrative behavior therapy