Sertraline and Naltrexone for Alcohol Dependence

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 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:	NCT00000440

Purpose

This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).

Condition	Intervention	Phase
Alcoholism	Drug: naltrexone (Revia) Drug: sertraline (Zoloft)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Sertraline and Naltrexone for Alcohol Dependents

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride Sertraline hydrochloride Sertraline

U.S. FDA Resources

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

Estimated Enrollment:	124
Estimated Study Completion Date:	September 2002

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets the criteria for alcohol dependence.
Abstinent from alcohol for a period of at least 5 days and not greater than 30 days.
Able to read English and complete study evaluations.
A stable residence and a telephone to ensure that subjects can be located during the study.

Exclusion Criteria:

Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence.
Current use of disulfiram (Antabuse) or a MAO Inhibitor.
Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania).
Major depression at the time of assessment.
Previous treatment with naltrexone (Revia) for alcohol dependence.
Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease.
Abstinent longer than 30 days prior to admission to program.
Hepatocellular disease or elevated bilirubin levels.
Females who are pregnant, nursing, or not using a reliable method of birth control.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000440

Locations

United States, New York
Department of Psychiatry, Mount Sinai School of Medicine
New York, New York, United States, 10029

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00000440 History of Changes
Other Study ID Numbers:	NIAAAFAR11222
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

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 13, 2012