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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00874003

Enrollment

Registered

2009-04-02

Start date

2004-04-30

Completion date

2009-02-28

Last updated

2009-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence

Keywords

alcohol dependence, anti-depressant, 5-HT, NE

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).

Interventions

DRUGmirtazapine

oral tablet, 30 mg daily

DRUGplacebo

oral tablet, 1 daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Alcohol consumption measured by alcohol diary (units/week).	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026