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