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

Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000451

Enrollment

198

Registered

1999-11-03

Start date

2003-01-31

Completion date

2005-11-30

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence, Alcoholism

Keywords

Alcoholism, Alcohol Dependence

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 sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.

Interventions

DRUGsertraline

16 week outpatient study

DRUGnaltrexone

16 week outpatient study

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Days abstinent	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026