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Antabuse in Severe Alcoholism: an Open Controlled Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Psykiatrisk Center Gentofte.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00431262
First Posted: February 5, 2007
Last Update Posted: March 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Psykiatrisk Center Gentofte
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antabuse in Severe Alcoholism: an Open Controlled Study

Resource links provided by NLM:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 1, 2007
First Posted: February 5, 2007
Last Update Posted: March 5, 2007
Last Verified: March 2007

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