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Completed

NCT Number: NCT00000440

Sertraline and Naltrexone for Alcohol Dependence

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).

Completed

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry, Mount Sinai School of Medicine

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

naltrexone (Revia)

Drug

sertraline (Zoloft)

Drug

Sponsors and collaborators

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Nih

Registry information

Official study title

Sertraline and Naltrexone for Alcohol Dependents

Important dates

Study completion
2002
First posted
Nov 3, 1999
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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