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Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
This study has been completed.
Study NCT00000451   Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First Received: November 2, 1999   Last Updated: May 6, 2008   History of Changes

November 2, 1999
May 6, 2008
January 2003
 
Days abstinent
Same as current
Complete list of historical versions of study NCT00000451 on ClinicalTrials.gov Archive Site
 
 
 
Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives

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.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
  • Alcoholism
  • Alcohol Dependence
  • Drug: sertraline
  • Drug: naltrexone
  • Experimental: Naltrexone plus Sertraline
  • Experimental: Naltrexone alone
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
198
November 2007
 

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000451
 
NIAAAOMA12028
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 
Principal Investigator: Dr. Stephanie O'Malley Yale University, New Haven, CT
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP