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

Primary Purpose

Alcoholism, Alcohol Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sertraline
naltrexone
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism, Alcohol Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Naltrexone plus Sertraline

Naltrexone alone

Outcomes

Primary Outcome Measures

Days abstinent

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
January 28, 2013
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000451
Brief Title
Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
Official Title
Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Dependence
Keywords
Alcoholism, Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Naltrexone plus Sertraline
Arm Title
2
Arm Type
Experimental
Arm Description
Naltrexone alone
Intervention Type
Drug
Intervention Name(s)
sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
16 week outpatient study
Intervention Type
Drug
Intervention Name(s)
naltrexone
Other Intervention Name(s)
Revia
Intervention Description
16 week outpatient study
Primary Outcome Measure Information:
Title
Days abstinent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Stephanie O'Malley
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
City
New Haven
State/Province
Connecticut
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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