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

This study has been completed.
Information provided by:
Sahlgrenska University Hospital, Sweden Identifier:
First received: April 1, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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 Intervention Phase
Alcohol Dependence Drug: mirtazapine Drug: placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Sahlgrenska University Hospital, Sweden:

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

Enrollment: 59
Study Start Date: April 2004
Study Completion Date: February 2009
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mirtazapine, tablet, 30 mg
Drug: mirtazapine
oral tablet, 30 mg daily
Placebo Comparator: sugar pill
Drug: placebo
oral tablet, 1 daily


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: April 1, 2009
Last Updated: April 1, 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 processed this record on September 21, 2017