Skip to main content
OpenTrials
Completed

NCT Number: NCT00000451

Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)

This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New Haven, Connecticut, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Alaska Native having biological Alaska Native ancestry.
  • Meets criteria for alcohol dependence.
  • Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.
  • Stable residence to ensure that subjects can be located during the study.

Exclusion criteria

  • Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.
  • Current use of disulfiram.
  • Psychotic or otherwise severely psychiatrically disabled.
  • Use of other psychotropic medications including antidepressants and anxiolytics.
  • Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.
  • Hepatocellular disease or elevated bilirubin levels.
  • Females who are pregnant, nursing, or not using a reliable method of birth control.
  • Probation or parole requirements that might interfere with participation in the study.
  • Involvement in alcohol treatment other than provided by the study or AA.
  • Use of monoamine oxidase inhibitors in the past month.
  • Current use of Type 1C antiarrhythmics propafenone and flecainide.

Treatment and study plan

Sertraline

Drug

16 week outpatient study

Other names: Zoloft

Naltrexone

Drug

16 week outpatient study

Other names: Revia

Primary outcomes

  1. Days abstinent

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Nov 3, 1999
Registry last updated
Jan 29, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.