Naltrexone Maintenance Treatment of Alcoholism

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:	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

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride Morphinan-3,14-diol, 17-(cyclopropylmethyl)-4,5-epoxy-6-methylene-, hydrochloride, (5alpha)- Nalmefene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title:	Nalmefene Maintenance Treatment of Alcoholism

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

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

Study ID Numbers:	NIAAAMAS10518
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000450
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Mental Disorders
Naltrexone
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Alcohol-Related Disorders
Nalmefene

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009