The Effects of Mirtazapine Versus Placebo on Alcohol Cons... | NCT00874003

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

NCT00874003

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Apr 2, 2009Estimated

Enrollment

59Actual

Phase

Phase 2

Conditions

Alcohol Dependence

Interventions

mirtazapine
placebo

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Jul 2006Actual

Completion Date

Feb 2009Actual

First Submitted Date

Apr 1, 2009

First Submission Date that Met QC Criteria

Apr 1, 2009

First Posted Date

Apr 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2009

Last Update Posted Date

Apr 2, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mirtazapine, tablet, 30 mg	Experimental	n=29	Drug: mirtazapine
sugar pill	Placebo Comparator	n=30	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mirtazapine	Drug	oral tablet, 30 mg daily	mirtazapine, tablet, 30 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alcohol consumption measured by alcohol diary (units/week).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea deBejczy, MD	Addiction Biology Unit	Study Director
Bo Söderpalm, MD, PhD	Addiction Biology Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Addiction Biology Unit		Gothenburg		413 45	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078785	Mirtazapine

Ancestor Terms

ID	Term
D003984	Dibenzazepines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided