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

April 1, 2009
April 1, 2009
April 2004
July 2006   (final data collection date for primary outcome measure)
Alcohol consumption measured by alcohol diary (units/week). [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers
The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Dependence
  • Drug: mirtazapine
    oral tablet, 30 mg daily
  • Drug: placebo
    oral tablet, 1 daily
  • Experimental: mirtazapine, tablet, 30 mg
    n=29
    Intervention: Drug: mirtazapine
  • Placebo Comparator: sugar pill
    n=30
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
February 2009
July 2006   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00874003
GOTABU-BO1
No
Bo Söderpalm/ MD, PhD, sponsor, Addiction Biology Unit, Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Sweden
Not Provided
Study Director: Andrea deBejczy, MD Addiction Biology Unit
Principal Investigator: Bo Söderpalm, MD, PhD Addiction Biology Unit
Sahlgrenska University Hospital, Sweden
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP