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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
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
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

No publications provided

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
Mental Disorders
Disulfiram
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013