Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism; Alcohol Dependence
Intervention: sertraline (Drug); naltrexone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Official(s) and/or principal investigator(s):
Dr. Stephanie O'Malley, Principal Investigator, Affiliation: Yale University, New Haven, CT
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.
Clinical Details
Official title: Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Days abstinent
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
New Haven, Connecticut, United States
Additional Information
Starting date: January 2003
Ending date: November 2007
Last updated: May 6, 2008
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