Naltrexone Maintenance Treatment of Alcoholism

This study has been completed.

First Received on November 2, 1999. Last Updated on July 21, 2010 History of Changes

Sponsor:	The Scripps Research Institute
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	The Scripps Research Institute
ClinicalTrials.gov Identifier:	NCT00000450

Purpose

The purpose of this study is to determine the long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. Those who respond to short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup.

Condition	Intervention	Phase
Alcoholism	Drug: naltrexone (Revia)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Nalmefene Maintenance Treatment of Alcoholism

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by The Scripps Research Institute:

Estimated Enrollment:	184
Estimated Study Completion Date:	April 2002

Eligibility

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

Criteria

Inclusion Criteria:

Meets criteria for alcohol dependence.
Expresses a desire to cut down or stop drinking.

Exclusion Criteria:

Currently meets criteria for dependence on substances other than alcohol.
History of opiate dependence or evidence of current opiate use.
Significant medical disorders that will increase potential risk or interfere with study participation.
Liver function tests more than 3 times normal or elevated bilirubin.
Female patients who are pregnant, nursing, or not using a reliable method of birth control.
Inability to understand and provide a consent form.
Treatment with an investigational drug during the previous month.
Prior treatment with naltrexone.
Chronic treatment with any narcotic-containing medications during the previous month.
Sensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists.
Current treatment with disulfiram.
More than 6 weeks of abstinence.
Meets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000450

Locations

United States, Florida
Department of Psychiatry, University of Miami School of Medicine
Miami, Florida, United States, 33136

Sponsors and Collaborators

The Scripps Research Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00000450 History of Changes
Other Study ID Numbers:	NIAAAMAS10518, R01AA010518
Study First Received:	November 2, 1999
Last Updated:	July 21, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012