Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)

Alcoholism Clinical Trial

Official title:

Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000451
• Other study ID #: NIAAAOMA12028
• Secondary ID: R01AA012028
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: January 28, 2013
• Start date: January 2003
• Est. completion date: November 2005

Study information

• Verified date: January 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: November 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days abstinent