Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: sertraline
  • 16 week outpatient study
• Drug: naltrexone
  • 16 week outpatient study

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Naltrexone plus Sertraline
• Experimental: 2
  • Naltrexone alone

Primary Measures

• Days abstinent

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000451

Study ID Number: NIAAAOMA12028

ClinicalTrials.gov Identifier: NCT00000451

Health Authority: United States: Federal Government