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Integrative Therapy in Alcoholism

H

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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