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

This study has been completed.

First Received on November 2, 1999. Last Updated on May 6, 2008 History of Changes

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00000451

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	Intervention	Phase
Alcoholism Alcohol Dependence	Drug: sertraline Drug: naltrexone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Ethanol Naltrexone Naltrexone hydrochloride Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Days abstinent

Enrollment:	198
Study Start Date:	January 2003
Study Completion Date:	November 2007

Arms	Assigned Interventions
Experimental: 1 Naltrexone plus Sertraline	Drug: naltrexone 16 week outpatient study Other Name: Revia
Experimental: 2 Naltrexone alone	Drug: sertraline 16 week outpatient study Other Name: Zoloft Drug: naltrexone 16 week outpatient study Other Name: Revia

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000451

Locations

United States, Connecticut

New Haven, Connecticut, United States

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Dr. Stephanie O'Malley

Yale University, New Haven, CT

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00000451 History of Changes
Other Study ID Numbers:	NIAAAOMA12028
Study First Received:	November 2, 1999
Last Updated:	May 6, 2008
Health Authority:	United States: Federal Government

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

Alcoholism
Alcohol Dependence

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Sertraline
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012