Integrative Therapy in Alcoholism | NCT00159107

Studies
Integrative Therapy in Alcoholism

NCT00159107

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Completed

Last Update Posted

Jan 30, 2008Estimated

Enrollment

371Actual

Phase

Phase 4

Conditions

Alcoholism

Interventions

Acamprosate
Integrative behavior therapy
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2008

Last Update Posted Date

Jan 30, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Heinrich-Heine University, DuesseldorfOTHER

Collaborators

Name	Class
German Federal Ministry of Education and Research	OTHER_GOV
German Addiction Research Network	OTHER
Merck Sharp & Dohme LLC	INDUSTRY
University of Bonn

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

371Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Experimental	Placebo +Integrative behavior therapy	Behavioral: Integrative behavior therapy Drug: Placebo
3	Experimental	Acamprosate + treatment as usual	Drug: Acamprosate
1	Experimental	Acamprosate + Integrative behavior therapy	Drug: Acamprosate Behavioral: Integrative behavior therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acamprosate	Drug	Acamprosate	1 3
Integrative behavior therapy

Measure	Description	Time Frame
Abstinence		3,6,12 months

Measure	Description	Time Frame
Social functioning		12 months
Cognitive functioning		12 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wolfgang Gaebel, Professor	Department of Psychiatry and Psychotherapy, University of Düsseldorf	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077443	Acamprosate

Ancestor Terms

ID	Term
D013654	Taurine
D017738	Alkanesulfonic Acids
D000473	Alkanes
D006839	Hydrocarbons, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided