Sertraline and Naltrexone for Alcohol Dependence

Completed · Phase 2

Conditions studied: Alcoholism

In brief

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).

Key facts

Study ID

NCT00000440

Run by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

People needed

124

Expected to finish

2002-09-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Psychiatry, Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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