Sertraline and Naltrexone for Alcohol Dependence
Phase 2
Completed
- Conditions
- Alcoholism
- Registration Number
- NCT00000440
- Lead Sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Psychiatry, Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Department of Psychiatry, Mount Sinai School of Medicine🇺🇸New York, New York, United States