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NCT00431262 Clinical Trial

Antabuse in Severe Alcoholism: an Open Controlled Study

Alcoholism Clinical Trial

Official title:
Antabuse in Severe Alcoholism: an Open Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00431262
Other study ID # EudraCT no. 2006-004921-27
Secondary ID
Status Recruiting
Phase Phase 4
First received February 1, 2007
Last updated March 2, 2007
Start date February 2007
Est. completion date June 2009

Study information
Verified date March 2007
Source Psykiatrisk Center Gentofte
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date June 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Alcoholism

- Living in the departments catchment area

Exclusion Criteria:

- Pregnancy

- Schizophrenia

- Bipolar disorder

- Other substance abuse

- Dementia

- Anorexia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• antabuse (disulfiram)

Locations
Country Name City State
Denmark Psykiatrisk Center Gentofte Hellerup

Sponsors (1)
Lead Sponsor Collaborator
Psykiatrisk Center Gentofte

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of patients in each group who have not been drinking alcohol after 6 months of treatment.
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