Aims

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Friday, February 9, 2007

ClinicalTrial - Antabuse in Severe Alcoholism: an Open Controlled Study

Antabuse in Severe Alcoholism: an Open Controlled Study

This study is not yet open for patient recruitment.Verified by Psykiatrisk Center Gentofte

February 2007

Sponsored by:
Psykiatrisk Center Gentofte
Information provided by:
Psykiatrisk Center Gentofte
ClinicalTrials.gov Identifier:
NCT00431262

Purpose
Newly detoxified alcoholics (N=60) are randomised to either 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 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: disulfiram

Phase IV

MedlinePlus related topics: Alcoholism

Study Type: InterventionalStudy Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Psykiatrisk Center Gentofte:
Primary Outcomes: The number of patients in each group who have not been drinking alcohol after 6 months of treatment.

Expected Total Enrollment: 60

Study start: February 2007;

Expected completion: March 2010

Last follow-up: June 2009;

Data entry closure: August 2009

Eligibility
Ages Eligible for Study: 18 Years - 70 Years,

Genders Eligible for Study: Both

Criteria
Inclusion Criteria:
Alcoholism
Living in the departments catchment area

Exclusion Criteria:
Pregnancy
Schizophrenia
Bipolar disorder
Other substance abuse
Dementia
Anorexia

Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00431262
Denmark Psykiatrisk Center Gentofte, Hellerup, 2900, Denmark

Jakob Ulrichsen, MD, ph.d., Principal InvestigatorJakob Ulrichsen, MD, ph.d., Principal Investigator

Study chairs or principal investigators
Jakob Ulrichsen, MD, ph.d., Principal Investigator, Psykiatrisk Center Gentofte

More Information
Study ID Numbers: EudraCT no. 2006-004921-27
Last Updated: February 1, 2007
Record first received: February 1, 2007
ClinicalTrials.gov Identifier: NCT00431262
Health Authority: Denmark: The Regional Committee on Biomedical Research

EthicsClinicalTrials.gov processed this record on 2007-02-08
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