Antabuse in Severe Alcoholism: an Open Controlled Study

This study is currently recruiting participants.

Verified by Psykiatrisk Center Gentofte, March 2007

Sponsored by:	Psykiatrisk Center Gentofte
Information provided by:	Psykiatrisk Center Gentofte
ClinicalTrials.gov Identifier:	NCT00431262

Purpose

Newly detoxified alcoholics (N=60) are randomised to either antabuse (disulfiram) treatment or the control group for a total of 6 months.All patients will receive cognitive behavioural treatment in groups. The hypothesis to be tested is that more of the patients who receive antabuse (disulfiram) will be alcohol free during the 6 months treatment period compared to the control group. The trial is open.

Condition	Intervention	Phase
Alcoholism	Drug: antabuse (disulfiram)	Phase IV

MedlinePlus related topics: Alcoholism

Drug Information available for: Disulfiram

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Antabuse in Severe Alcoholism: an Open Controlled Study

Further study details as provided by Psykiatrisk Center Gentofte:

Primary Outcome Measures:

The number of patients in each group who have not been drinking alcohol after 6 months of treatment.

Estimated Enrollment:	60
Study Start Date:	February 2007
Estimated Study Completion Date:	June 2009

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Alcoholism
Living in the departments catchment area

Exclusion Criteria:

Pregnancy
Schizophrenia
Bipolar disorder
Other substance abuse
Dementia
Anorexia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431262

Locations

Denmark
Psykiatrisk Center Gentofte	Recruiting
Hellerup, Denmark, 2900
Contact: Jakob Ulrichsen, MD, ph.d. (45) 3977 3650 jaul@geh.regionh.dk
Principal Investigator: Jakob Ulrichsen, MD, ph.d.

Sponsors and Collaborators

Psykiatrisk Center Gentofte

Investigators

Principal Investigator:

Jakob Ulrichsen, MD, ph.d.

Psykiatrisk Center Gentofte

More Information

Study ID Numbers:	EudraCT no. 2006-004921-27
Study First Received:	February 1, 2007
Last Updated:	March 2, 2007
ClinicalTrials.gov Identifier:	NCT00431262
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Psykiatrisk Center Gentofte:

alcoholism
antabuse
disulfiram
abstinence
cognitive behavioural therapy

Study placed in the following topic categories:

Disulfiram
Mental Disorders
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors

Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents

ClinicalTrials.gov processed this record on January 16, 2009