NCT00159107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 30, 2008

Status Verified

October 1, 2007

First QC Date

September 7, 2005

Last Update Submit

January 29, 2008

Conditions

Alcoholism

Keywords

alcoholismabstinence enhancementpsychotherapycognitive behavior therapy vs. supportive counselingAcamprosate vs. Placebomulti-center study

Outcome Measures

Primary Outcomes (1)

  • Abstinence

    3,6,12 months

Secondary Outcomes (2)

  • Social functioning

    12 months

  • Cognitive functioning

    12 months

Study Arms (3)

2

EXPERIMENTAL

Placebo +Integrative behavior therapy

Behavioral: Integrative behavior therapyDrug: Placebo

3

EXPERIMENTAL

Acamprosate + treatment as usual

Drug: Acamprosate

1

EXPERIMENTAL

Acamprosate + Integrative behavior therapy

Drug: AcamprosateBehavioral: Integrative behavior therapy

Interventions

AcamprosateDRUG

Acamprosate

13
Integrative behavior therapyBEHAVIORAL

Integrative behavior therapy

12
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSMIV criteria of alcoholism
  • Age between 25 and 60
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 40629, Germany

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TaurineAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Wolfgang Gaebel, Professor

    Department of Psychiatry and Psychotherapy, University of Düsseldorf

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

May 1, 2003

Study Completion

December 1, 2006

Last Updated

January 30, 2008

Record last verified: 2007-10

Locations

DE(1)