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

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Yale University

Status and phase

Completed
Phase 2

Conditions

Alcoholism
Alcohol Dependence

Treatments

Drug: naltrexone
Drug: sertraline

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00000451
NIAAAOMA12028
R01AA012028 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

198 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

198 participants in 2 patient groups

1
Experimental group
Description:
Naltrexone plus Sertraline
Treatment:
Drug: naltrexone
2
Experimental group
Description:
Naltrexone alone
Treatment:
Drug: sertraline
Drug: naltrexone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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