Sertraline and Naltrexone for Alcohol Dependence

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Alcoholism

Treatments

Drug: naltrexone (Revia)
Drug: sertraline (Zoloft)

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000440
NIAAAFAR11222

Details and patient eligibility

About

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).

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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