Sertraline Pharmacotherapy for Alcoholism Subtypes

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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. This involved administering sertraline (to a maximum of 200 mg/day) or an inactive placebo for a 14-week treatment period.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UConn Health
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Sertraline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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