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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

Tracking Information
First Submitted Date  ICMJE February 1, 2007
First Posted Date  ICMJE February 5, 2007
Last Update Posted Date March 5, 2007
Study Start Date  ICMJE February 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2007)
The number of patients in each group who have not been drinking alcohol after 6 months of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antabuse in Severe Alcoholism: an Open Controlled Study
Official Title  ICMJE Antabuse in Severe Alcoholism: an Open Controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE Drug: antabuse (disulfiram)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: February 1, 2007)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Alcoholism
  • Living in the departments catchment area

Exclusion Criteria:

  • Pregnancy
  • Schizophrenia
  • Bipolar disorder
  • Other substance abuse
  • Dementia
  • Anorexia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00431262
Other Study ID Numbers  ICMJE EudraCT no. 2006-004921-27
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Psykiatrisk Center Gentofte
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jakob Ulrichsen, MD, ph.d. Psykiatrisk Center Gentofte
PRS Account Psykiatrisk Center Gentofte
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP