Integrative Therapy in Alcoholism

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00159107

Enrollment

371

Registered

2005-09-12

Start date

2003-05-31

Completion date

2006-12-31

Last updated

2008-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

Keywords

alcoholism, abstinence enhancement, psychotherapy, cognitive behavior therapy vs. supportive counseling, Acamprosate vs. Placebo, multi-center study

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.

Interventions

DRUGAcamprosate

Acamprosate

BEHAVIORALIntegrative behavior therapy

Integrative behavior therapy

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Abstinence	3,6,12 months

Secondary

Measure	Time frame
Social functioning	12 months
Cognitive functioning	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026