Back to resultsThe Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
mirtazapine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring alcohol dependence, anti-depressant, 5-HT, NE
Eligibility 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
Sites / Locations
- Addiction Biology Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
mirtazapine, tablet, 30 mg
sugar pill
Arm Description
n=29
n=30
Outcomes
Primary Outcome Measures
Alcohol consumption measured by alcohol diary (units/week).
Secondary Outcome Measures
Full Information
NCT ID
NCT00874003
First Posted
April 1, 2009
Last Updated
April 1, 2009
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT00874003
Brief Title
The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers
Official Title
The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
alcohol dependence, anti-depressant, 5-HT, NE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mirtazapine, tablet, 30 mg
Arm Type
Experimental
Arm Description
n=29
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
n=30
Intervention Type
Drug
Intervention Name(s)
mirtazapine
Intervention Description
oral tablet, 30 mg daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral tablet, 1 daily
Primary Outcome Measure Information:
Title
Alcohol consumption measured by alcohol diary (units/week).
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea deBejczy, MD
Organizational Affiliation
Addiction Biology Unit
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bo Söderpalm, MD, PhD
Organizational Affiliation
Addiction Biology Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction Biology Unit
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
12. IPD Sharing Statement
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The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers
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