Back to resultsIntegrative Therapy in Alcoholism
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Acamprosate
Integrative behavior therapy
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring alcoholism, abstinence enhancement, psychotherapy, cognitive behavior therapy vs. supportive counseling, Acamprosate vs. Placebo, multi-center study
Eligibility Criteria
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
Sites / Locations
- Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
2
3
1
Arm Description
Placebo +Integrative behavior therapy
Acamprosate + treatment as usual
Acamprosate + Integrative behavior therapy
Outcomes
Primary Outcome Measures
Abstinence
Secondary Outcome Measures
Social functioning
Cognitive functioning
Full Information
NCT ID
NCT00159107
First Posted
September 7, 2005
Last Updated
January 29, 2008
Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
German Federal Ministry of Education and Research, German Addiction Research Network, Merck Sharp & Dohme LLC, University of Bonn, Universität Duisburg-Essen, University of Homburg, Psychosomatic Clinic of Bergisch Gladbach
1. Study Identification
Unique Protocol Identification Number
NCT00159107
Brief Title
Integrative Therapy in Alcoholism
Official Title
Acamprosate and Integrative Behavior Therapy in the Outpatient Treatment of Alcohol Dependents
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
German Federal Ministry of Education and Research, German Addiction Research Network, Merck Sharp & Dohme LLC, University of Bonn, Universität Duisburg-Essen, University of Homburg, Psychosomatic Clinic of Bergisch Gladbach
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
alcoholism, abstinence enhancement, psychotherapy, cognitive behavior therapy vs. supportive counseling, Acamprosate vs. Placebo, multi-center study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
371 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
Placebo +Integrative behavior therapy
Arm Title
3
Arm Type
Experimental
Arm Description
Acamprosate + treatment as usual
Arm Title
1
Arm Type
Experimental
Arm Description
Acamprosate + Integrative behavior therapy
Intervention Type
Drug
Intervention Name(s)
Acamprosate
Intervention Description
Acamprosate
Intervention Type
Behavioral
Intervention Name(s)
Integrative behavior therapy
Intervention Description
Integrative behavior therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Abstinence
Time Frame
3,6,12 months
Secondary Outcome Measure Information:
Title
Social functioning
Time Frame
12 months
Title
Cognitive functioning
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Gaebel, Professor
Organizational Affiliation
Department of Psychiatry and Psychotherapy, University of Düsseldorf
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany
City
Düsseldorf
State/Province
North Rhine-Westfalia
ZIP/Postal Code
40629
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Integrative Therapy in Alcoholism
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