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

Sahlgrenska University Hospital

Status and phase: Completed; Phase 2

Conditions: Alcohol Dependence

Treatments: Drug: placebo; Drug: mirtazapine

Study type: Interventional

Funder types: Other

Identifiers

NCT00874003

GOTABU-BO1

Details and patient eligibility

About

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).

Enrollment: 59 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

mirtazapine, tablet, 30 mg

Experimental group

Description:

n=29

Treatment:

Drug: mirtazapine

sugar pill

Placebo Comparator group

Description:

n=30

Treatment:

Drug: placebo