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Cognitive behavior therapy |
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Clinical Trial: Integrative Therapy in Alcoholism
This study is currently recruiting patients.
Verified by Heinrich-Heine University, Duesseldorf September 2005
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Purpose
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 372 patients is to be randomly assigned immediately after detoxification to one of three different outpatient treat-ment conditions.
| Condition | Intervention | Phase |
|---|---|---|
| Alcoholism | Drug: Acamprosate Behavior: Cognitive Behavior Therapy, Supportive Counseling | Phase IV |
MedlinePlus related topics: Alcoholism
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Acamprosate and Integrative Behavior Therapy in the Outpatient Treatment of Alcohol Dependents
Further Study Details:
Primary Outcomes: Abstinence; Alcohol consumption
Secondary Outcomes: Social functioning; Cognitive functioning
Expected Total Enrollment: 372
Secondary Outcomes: Social functioning; Cognitive functioning
Expected Total Enrollment: 372
Study start: May 2003; Expected completion: November 2007
Last follow-up: December 2006; Data entry closure: March 2007
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.
Eligibility
Ages Eligible for Study: 25 Years - 60 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00159107
Wolfgang Gaebel, Professor 00 49/ 211/ 922 2001 wolfgang.gaebel@uni-duesseldorf.de
Wolfgang Woelwer, PD Dr. 00 49/ 211/ 922 2002 wolfgang.woelwer@uni-duesseldorf.de
Wolfgang Woelwer, PD Dr. 00 49/ 211/ 922 2002 wolfgang.woelwer@uni-duesseldorf.de
Germany, North Rhine-Westfalia
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; Recruiting
Wolfgang Gaebel, Professor 00 49/ 211/ 922 2001 wolfgang.gaebel@uni-duesseldorf.de
Wolfgang Woelwer, PD Dr. 00 49/ 211/ 922 2002 wolfgang.woelwer@uni-duesseldorf.de
Wolfgang Gaebel, Professor, Principal Investigator
Wolfgang Maier, Professor, Sub-Investigator
Peter Falkai, Professor, Sub-Investigator
T. Kuhlmann, PD Dr., Sub-Investigator
Christian Ohmann, Professor, Sub-Investigator
Johannes Siegrist, Professor, Sub-Investigator
Wolfgang Woelwer, PD Dr. 00 49/ 211/ 922 2002 wolfgang.woelwer@uni-duesseldorf.de
Wolfgang Gaebel, Professor, Principal Investigator
Wolfgang Maier, Professor, Sub-Investigator
Peter Falkai, Professor, Sub-Investigator
T. Kuhlmann, PD Dr., Sub-Investigator
Christian Ohmann, Professor, Sub-Investigator
Johannes Siegrist, Professor, Sub-Investigator
Study chairs or principal investigators
Wolfgang Gaebel, Professor, Study Chair, Department of Psychiatry and Psychotherapy, University of Düsseldorf
More Information
Study ID Numbers: 01EB0133
Last Updated: September 11, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00159107
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 11, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00159107
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
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