Sertraline and Naltrexone for Alcohol Dependence
Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism
Intervention: naltrexone (Revia) (Drug); sertraline (Zoloft) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Summary
This study is a double-blind, placebo-controlled outpatient trial to improve, through the
addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent
individuals currently taking naltrexone (Revia).
Clinical Details
Official title: Sertraline and Naltrexone for Alcohol Dependents
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Meets the criteria for alcohol dependence.
- Abstinent from alcohol for a period of at least 5 days and not greater than 30 days.
- Able to read English and complete study evaluations.
- A stable residence and a telephone to ensure that subjects can be located during the
study.
Exclusion Criteria:
- Currently meets criteria for substance abuse or dependence with the exception of
nicotine dependence.
- Current use of disulfiram (Antabuse) or a MAO Inhibitor.
- Psychotic or otherwise severely psychiatrically disabled (i. e., depressed, suicidal,
current mania).
- Major depression at the time of assessment.
- Previous treatment with naltrexone (Revia) for alcohol dependence.
- Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac
disease.
- Abstinent longer than 30 days prior to admission to program.
- Hepatocellular disease or elevated bilirubin levels.
- Females who are pregnant, nursing, or not using a reliable method of birth control.
Locations and Contacts
Department of Psychiatry, Mount Sinai School of Medicine, New York, New York 10029, United States
Additional Information
Ending date: September 2002
Last updated: June 23, 2005
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