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

NCT00000451 | Completed Phase 2

• 2 other identifiers: NIAAAOMA12028R01AA012028
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcoholism; Alcohol Dependence

Keywords

Alcoholism; Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

• Days abstinent

Study Arms (2)

1

EXPERIMENTAL

Naltrexone plus Sertraline

Drug: naltrexone

2

EXPERIMENTAL

Naltrexone alone

Drug: sertraline; Drug: naltrexone

Interventions

sertraline DRUG

16 week outpatient study

Also known as: Zoloft

2

naltrexone DRUG

16 week outpatient study

Also known as: Revia

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Unknown Facility

New Haven, Connecticut, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Sertraline; Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes

Study Officials

• Dr. Stephanie O'Malley

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: January 1, 2003
• Primary Completion: August 1, 2005
• Study Completion: November 1, 2005
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

US (1)