Antabuse in Severe Alcoholism: an Open Controlled Study

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2007 by Psykiatrisk Center Gentofte.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Psykiatrisk Center Gentofte

ClinicalTrials.gov Identifier:

NCT00431262

First received: February 1, 2007

Last updated: March 2, 2007

Last verified: March 2007

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Antabuse in Severe Alcoholism: an Open Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism and Alcohol Abuse

Drug Information available for: Disulfiram

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Keywords provided by Psykiatrisk Center Gentofte:


alcoholism antabuse disulfiram abstinence cognitive behavioural therapy

Additional relevant MeSH terms:


Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders	Disulfiram Alcohol Deterrents Acetaldehyde Dehydrogenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016

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