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CompletedNCT00874003Updated Apr 2, 2009

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

A Phase 2 interventional study of mirtazapine and placebo in Alcohol Dependence, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-04-02.

Sponsored by Sahlgrenska University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study 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).

02

Conditions studied

  • Alcohol Dependence

Keywords

  • alcohol dependence
  • anti-depressant
  • 5-HT
  • NE
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 59 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 18-65 years of age
  • male sex
  • alcohol high consumption
  • signed informed consent

Exclusion criteria

Exclusion Criteria:

  • psychiatric disorders (except nicotine and alcohol dependence)
  • severe somatic disorders
  • inadequate knowledge of the Swedish language
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    mirtazapine, tablet, 30 mg

    n=29

    Drug: mirtazapine

  • Placebo comparator
    sugar pill

    n=30

    Drug: placebo

Interventions

  • Drugmirtazapine

    oral tablet, 30 mg daily

  • Drugplacebo

    oral tablet, 1 daily

06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • Addiction Biology Unit
    Gothenburg, 413 45, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00874003
Lead sponsor
Sahlgrenska University Hospital
First posted
Apr 2, 2009
Start date
Apr 2004
Primary completion
Jul 2006
Completion
Feb 2009
Last update
Apr 2, 2009

Study contacts

Andrea deBejczy, MD
study director · Addiction Biology Unit
Bo Söderpalm, MD, PhD
principal investigator · Addiction Biology Unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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