NCT00874003

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
Last Updated

April 2, 2009

Status Verified

March 1, 2009

Enrollment Period

2.2 years

First QC Date

April 1, 2009

Last Update Submit

April 1, 2009

Conditions

Alcohol Dependence

Keywords

alcohol dependenceanti-depressant5-HTNE

Outcome Measures

Primary Outcomes (1)

  • Alcohol consumption measured by alcohol diary (units/week).

Study Arms (2)

mirtazapine, tablet, 30 mg

EXPERIMENTAL

n=29

Drug: mirtazapine

sugar pill

PLACEBO COMPARATOR

n=30

Drug: placebo

Interventions

mirtazapineDRUG

oral tablet, 30 mg daily

mirtazapine, tablet, 30 mg
placeboDRUG

oral tablet, 1 daily

sugar pill

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • male sex
  • alcohol high consumption
  • signed informed consent

You may not qualify if:

  • psychiatric disorders (except nicotine and alcohol dependence)
  • severe somatic disorders
  • inadequate knowledge of the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addiction Biology Unit

Gothenburg, 413 45, Sweden

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Andrea deBejczy, MD

    Addiction Biology Unit

    STUDY DIRECTOR

  • Bo Söderpalm, MD, PhD

    Addiction Biology Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

April 1, 2004

Primary Completion

July 1, 2006

Study Completion

February 1, 2009

Last Updated

April 2, 2009

Record last verified: 2009-03

Locations

SE(1)