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Sertraline and Naltrexone for Alcohol Dependence - Article


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Sertraline

Zoloft 




Clinical Trial: Sertraline and Naltrexone for Alcohol Dependence

This study has been completed.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

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).

Condition Treatment or Intervention Phase
Alcoholism
 Drug: naltrexone (Revia)
 Drug: sertraline (Zoloft)
Phase II

MedlinePlus related topics:  Alcoholism

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Official Title: Sertraline and Naltrexone for Alcohol Dependents

Further Study Details: 

Expected Total Enrollment:  124

Study completion: September 2002

Eligibility

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  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.

Location Information


New York
      Department of Psychiatry, Mount Sinai School of Medicine, New York,  New York,  10029,  United States

More Information

Study ID Numbers:  NIAAAFAR11222
Record last reviewed:  November 2004
Last Updated:  November 22, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000440
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



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December 5, 2009



Page Updated: June 1, 2005
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