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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00874003
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : April 2, 2009
Information provided by:
Sahlgrenska University Hospital, Sweden

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).

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: mirtazapine Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial
Study Start Date : April 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Mirtazapine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: mirtazapine, tablet, 30 mg
Drug: mirtazapine
oral tablet, 30 mg daily
Placebo Comparator: sugar pill
Drug: placebo
oral tablet, 1 daily

Primary Outcome Measures :
  1. Alcohol consumption measured by alcohol diary (units/week).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00874003

Addiction Biology Unit
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Study Director: Andrea deBejczy, MD Addiction Biology Unit
Principal Investigator: Bo Söderpalm, MD, PhD Addiction Biology Unit

Responsible Party: Bo Söderpalm/ MD, PhD, sponsor, Addiction Biology Unit, Sahlgrenska University Hospital, Sweden Identifier: NCT00874003     History of Changes
Other Study ID Numbers: GOTABU-BO1
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: April 2, 2009
Last Verified: March 2009

Keywords provided by Sahlgrenska University Hospital, Sweden:
alcohol dependence

Additional relevant MeSH terms:
Alcohol Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation