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Home > "D" Clinical Trials Conditions > Drug Therapy for Alcohol Dependence in Alaska Natives (naltrexone/sertraline)  Drug Therapy for Alcohol Dependence in Alaska Natives (naltrexone/sertraline)
Drug Therapy for Alcohol Dependence in Alaska Natives (naltrexone/sertraline)
For Condition: Alcoholism
Status: Recruiting
Sponsor(s): National Institute on Alcohol Abuse and Alcoholism (NIAAA) ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 198
Location and Contact Information:
Overall Study Official:
Dr.O'Malley, Principal Investigator, Yale University, New Haven, CT
South East Alaska Regional Health Consortium *Recruiting*
Sitka, Alaska, 99835
United States
Recruiting Dr. Robin 907-966-2411
Additional Information:
Study ID Numbers: NIAAAOMA12028;
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000451
Other Alcoholism Studies:
1. Pharmacologic Relapse Prevention for Alcoholic Smokers
2. Drug Therapy for Alcohol Dependence in Alaska Natives (naltrexone/sertraline)
3. Ondansetron Treatment for Alcoholism
4. Sertraline and Cognitive Therapy in Depressed Alcoholics
5. Drug Treatment for Alcoholics with Post-Traumatic Stress Disorder
Related Studies:
Other Alcoholism Clinical Trials
Other Alaska Clinical Trials
Other Sitka Clinical Trials
Drug Therapy for Alcohol Dependence in Alaska Natives (naltrexone/sertraline)
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