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

This study has been completed.

Sponsored by:	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

MedlinePlus related topics: Alcoholism

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives

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
1: Experimental Naltrexone plus Sertraline	Drug: naltrexone 16 week outpatient study
2: Experimental Naltrexone alone	Drug: sertraline 16 week outpatient study Drug: naltrexone 16 week outpatient study

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

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

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

Alcoholism
Alcohol Dependence

Study placed in the following topic categories:

Mental Disorders
Naltrexone
Alcoholism
Substance-Related Disorders
Sertraline

Disorders of Environmental Origin
Alcohol-Related Disorders
Serotonin
Ethanol

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Serotonin Agents
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009