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Antabuse in Severe Alcoholism: an Open Controlled Study

Primary Purpose

Alcoholism

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
antabuse (disulfiram)
Sponsored by
Psykiatrisk Center Gentofte
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring alcoholism, antabuse, disulfiram, abstinence, cognitive behavioural therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Alcoholism
  • Living in the departments catchment area

Exclusion Criteria:

  • Pregnancy
  • Schizophrenia
  • Bipolar disorder
  • Other substance abuse
  • Dementia
  • Anorexia

Sites / Locations

  • Psykiatrisk Center GentofteRecruiting

Outcomes

Primary Outcome Measures

The number of patients in each group who have not been drinking alcohol after 6 months of treatment.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2007
Last Updated
March 2, 2007
Sponsor
Psykiatrisk Center Gentofte
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1. Study Identification

Unique Protocol Identification Number
NCT00431262
Brief Title
Antabuse in Severe Alcoholism: an Open Controlled Study
Official Title
Antabuse in Severe Alcoholism: an Open Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Psykiatrisk Center Gentofte

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
alcoholism, antabuse, disulfiram, abstinence, cognitive behavioural therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
antabuse (disulfiram)
Primary Outcome Measure Information:
Title
The number of patients in each group who have not been drinking alcohol after 6 months of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Alcoholism Living in the departments catchment area Exclusion Criteria: Pregnancy Schizophrenia Bipolar disorder Other substance abuse Dementia Anorexia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Ulrichsen, MD, ph.d.
Organizational Affiliation
Psykiatrisk Center Gentofte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psykiatrisk Center Gentofte
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakob Ulrichsen, MD, ph.d.
Phone
(45) 3977 3650
Email
jaul@geh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Jakob Ulrichsen, MD, ph.d.

12. IPD Sharing Statement

Learn more about this trial

Antabuse in Severe Alcoholism: an Open Controlled Study

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