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Drug Therapy for Alcohol Dependence in Alaska Natives (naltrexone/sertraline) - Article


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Sertraline Oral Solution

Zoloft Oral Solution 




Clinical Trial: Drug Therapy for Alcohol Dependence in Alaska Natives (naltrexone/sertraline)

This study is no longer recruiting patients.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

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.

Condition Treatment or Intervention Phase
Alcoholism
 Drug: sertraline (Zoloft)
 Drug: naltrexone (Revia)
Phase II

MedlinePlus related topics:  Alcoholism

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives

Further Study Details: 

Expected Total Enrollment:  198

Study completion: September 2004

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  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.

Location Information


Alaska
      South East Alaska Regional Health Consortium, Sitka,  Alaska,  99835,  United States

Study chairs or principal investigators

Dr. Stephanie O'Malley,  Principal Investigator,  Yale University, New Haven, CT   

More Information

Study ID Numbers:  NIAAAOMA12028
Record last reviewed:  November 2004
Last Updated:  November 22, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000451
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



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November 27, 2009



Page Updated: June 1, 2005
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