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

This study has been completed.

First Received: April 1, 2009 No Changes Posted

Sponsored by:	Sahlgrenska University Hospital, Sweden
Information provided by:	Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:	NCT00874003

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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: Ethanol 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
mirtazapine, tablet, 30 mg: Experimental n=29	Drug: mirtazapine oral tablet, 30 mg daily
sugar pill: Placebo Comparator 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:	Addiction Biology Unit, Sahlgrenska University Hospital, Sweden ( Bo Söderpalm/ MD, PhD, sponsor )
Study ID Numbers:	GOTABU-BO1
Study First Received:	April 1, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00874003 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Sahlgrenska University Hospital, Sweden:

alcohol dependence
anti-depressant
5-HT
NE

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Drinking Behavior
Psychotropic Drugs
Disorders of Environmental Origin
Adrenergic alpha-Antagonists
Alcohol Drinking
Mirtazapine
Serotonin
Histamine
Antidepressive Agents, Tricyclic

Histamine Antagonists
Mental Disorders
Alcoholism
Substance-Related Disorders
Histamine phosphate
Histamine H1 Antagonists
Adrenergic Antagonists
Alcohol-Related Disorders
Antidepressive Agents
Ethanol

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Drinking Behavior
Psychotropic Drugs
Histamine Agents
Disorders of Environmental Origin
Adrenergic alpha-Antagonists
Alcohol Drinking
Mirtazapine
Pharmacologic Actions

Antidepressive Agents, Tricyclic
Histamine Antagonists
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Histamine H1 Antagonists
Adrenergic Antagonists
Alcohol-Related Disorders
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 11, 2009