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Completed

NCT Number: NCT00159107

Integrative Therapy in Alcoholism

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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, 40629, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acamprosate

Drug

Acamprosate

Integrative behavior therapy

Behavioral

Integrative behavior therapy

Placebo

Drug

Placebo

Primary outcomes

  1. Abstinence

    Time frame: 3,6,12 months

Secondary outcomes

  1. Social functioning

    Time frame: 12 months

  2. Cognitive functioning

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • German Addiction Research Network
  • German Federal Ministry of Education and Research
  • Merck Sharp & Dohme LLC
  • Psychosomatic Clinic of Bergisch Gladbach
  • University of Bonn
  • University of Homburg
  • Universität Duisburg-Essen

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Jan 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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