Status:
COMPLETED
Sertraline Pharmacotherapy for Alcoholism Subtypes
Lead Sponsor:
UConn Health
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether Sertraline, compared to placebo, is effective in the treatment of alcohol dependence as a function of the subtype of alcoholic patient being treated. ...
Detailed Description
In an effort to broaden the options for pharmacotherapy of alcoholism, this study will examine the effects of sertraline, a selective serotonin reuptake inhibitor (SSRI), for the treatment of alcohol ...
Eligibility Criteria
Inclusion
- Current episode (i.e., in the preceding month) of alcohol dependence defined by Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) criteria
- 18-65 years of age
- Abstinent from alcohol for a period of at least 3 days prior to baseline research assessment
- Able to read English and complete study evaluations
- Male, or if female, without active reproductive potential
- Participants will have signed informed consent
Exclusion
- Currently meets criteria for dependence on a psychoactive substance other than alcohol and nicotine
- Regular use of psychoactive drugs including anxiolytics and antidepressants
- Current use of disulfiram or naltrexone
- Current major depression or psychosis (or other severe psychiatric disability e.g., suicidality, current mania)
- Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac pathology, which in the opinion of the evaluating physician would preclude the patient from study adherence or be of potential harm to the subject
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00368550
Start Date
February 1 2004
End Date
December 1 2009
Last Update
June 21 2011
Active Locations (1)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030