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

S

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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