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Antabuse in Severe Alcoholism: an Open Controlled Study

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.
 
ClinicalTrials.gov Identifier: NCT00431262
Recruitment Status : Unknown
Verified March 2007 by Psykiatrisk Center Gentofte.
Recruitment status was:  Recruiting
First Posted : February 5, 2007
Last Update Posted : March 5, 2007
Sponsor:
Information provided by:
Psykiatrisk Center Gentofte

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alcoholism Drug: antabuse (disulfiram) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antabuse in Severe Alcoholism: an Open Controlled Study
Study Start Date : February 2007
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Disulfiram

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The number of patients in each group who have not been drinking alcohol after 6 months of treatment.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Jakob Ulrichsen, MD, ph.d. Psykiatrisk Center Gentofte
More Information
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ClinicalTrials.gov Identifier: NCT00431262    
Other Study ID Numbers: EudraCT no. 2006-004921-27
First Posted: February 5, 2007    Key Record Dates
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:
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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