Status:

COMPLETED

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

Lead Sponsor:

Yale University

Collaborating Sponsors:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Conditions:

Alcoholism

Alcohol Dependence

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

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 se...

Eligibility Criteria

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.

Key Trial Info

Start Date :

January 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2005

Estimated Enrollment :

198 Patients enrolled

Trial Details

Trial ID

NCT00000451

Start Date

January 1 2003

End Date

November 1 2005

Last Update

January 29 2013

Active Locations (1)

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1

New Haven, Connecticut, United States