Naltrexone Treatment for Alcoholism

This study has been completed.

First Received on November 2, 1999. Last Updated on May 13, 2010 History of Changes

Sponsor:	Johns Hopkins University
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00000438

Purpose

This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Primary Purpose: Treatment
Official Title:	Naltrexone Treatment for Alcoholism: Predicting Outcome

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 Johns Hopkins University:

Estimated Enrollment:	192
Estimated Study Completion Date:	March 2003

Eligibility

Ages Eligible for Study:	30 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets criteria for alcohol dependence.
Committed to alcohol abstinence as a treatment goal.
Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status.

Exclusion Criteria:

Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine).
Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy.
Females who are pregnant, lactating, or not using a reliable method of contraception.
Currently experiencing a serious medical condition that would place them at risk or interfere with study participation.
Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.
Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone.
Vocabulary below the 5th grade reading level.
Abnormal MRI scan.
HIV infection due to the neurological sequelae.
Significant central nervous system diseases.
Seizure disorder or history of closed head trauma.
Neuroendocrine disorders.
Treatment with opiates within the last six months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000438

Locations

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Johns Hopkins University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

No publications provided

Responsible Party:	Mary E. McCaul, Ph.D., Professor, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00000438 History of Changes
Other Study ID Numbers:	NIAAAMCC11855, R01AA011855
Study First Received:	November 2, 1999
Last Updated:	May 13, 2010
Health Authority:	United States: Institutional Review Board

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 09, 2012