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NCT00874003 Clinical Trial

The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers

Alcohol Dependence Clinical Trial

Official title:
The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00874003
Other study ID # GOTABU-BO1
Secondary ID
Status Completed
Phase Phase 2
First received April 1, 2009
Last updated April 1, 2009
Start date April 2004
Est. completion date February 2009

Study information
Verified date March 2009
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind placebo controlled clinical trial with parallel group design(N=59).

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date February 2009
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 18-65 years of age

- male sex

- alcohol high consumption

- signed informed consent

Exclusion Criteria:

- psychiatric disorders (except nicotine and alcohol dependence)

- severe somatic disorders

- inadequate knowledge of the Swedish language

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• mirtazapine
oral tablet, 30 mg daily
• placebo
oral tablet, 1 daily

Locations
Country Name City State
Sweden Addiction Biology Unit Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Alcohol consumption measured by alcohol diary (units/week). No
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