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

Phase 2

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: mirtazapine; Drug: placebo

• Registration Number: NCT00874003
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2006-07
• Study Completion: 2009-02
• Status Verified: 2009-03
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Last Update Submitted: 2009-04-01
• Study First Posted: 2009-04-02
• Last Update Posted: 2009-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mirtazapine, tablet, 30 mg	mirtazapine	n=29
sugar pill	placebo	n=30

Primary Outcome Measures

Name	Time	Method
Alcohol consumption measured by alcohol diary (units/week).

Trial Locations

Locations (1)

Addiction Biology Unit; 🇸🇪 Gothenburg, Sweden