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

January 28, 2013 updated by: Yale University

Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Naltrexone plus Sertraline
Drug: naltrexone
16 week outpatient study
Other Names:
  • Revia
EXPERIMENTAL: 2
Naltrexone alone
Drug: naltrexone
16 week outpatient study
Other Names:
  • Revia
Drug: sertraline
16 week outpatient study
Other Names:
  • Zoloft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Days abstinent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Dr. Stephanie O'Malley, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (ACTUAL)

August 1, 2005

Study Completion (ACTUAL)

November 1, 2005

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

November 2, 1999

First Posted (ESTIMATE)

November 3, 1999

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAOMA12028
  • R01AA012028 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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