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

This study has been completed.
Sponsor:
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT00874003
First received: April 1, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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

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

Primary Outcome Measures:
  • Alcohol consumption measured by alcohol diary (units/week). [ Designated as safety issue: No ]

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
n=29
 Drug: mirtazapine
oral tablet, 30 mg daily
Placebo Comparator: sugar pill
n=30
 Drug: placebo
oral tablet, 1 daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874003

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

No publications provided

Responsible Party: Bo Söderpalm/ MD, PhD, sponsor, Addiction Biology Unit, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT00874003     History of Changes
Other Study ID Numbers: GOTABU-BO1
Study First Received: April 1, 2009
Last Updated: April 1, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by Sahlgrenska University Hospital, Sweden:
alcohol dependence
anti-depressant
5-HT
NE

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

ClinicalTrials.gov processed this record on May 23, 2013