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

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).

Completed

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Addiction Biology Unit

Gothenburg, 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mirtazapine

Drug

oral tablet, 30 mg daily

Placebo

Drug

oral tablet, 1 daily

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2009
First posted: Apr 2, 2009
Registry last updated: Apr 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed