Naltrexone Treatment for Alcoholism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000438
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : May 14, 2010
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Johns Hopkins University

Brief Summary:
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 or disease Intervention/treatment Phase
Alcoholism Drug: naltrexone (Revia) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 192 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Naltrexone Treatment for Alcoholism: Predicting Outcome
Study Completion Date : March 2003

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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000438

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)

Responsible Party: Mary E. McCaul, Ph.D., Professor, Johns Hopkins University Identifier: NCT00000438     History of Changes
Other Study ID Numbers: NIAAAMCC11855
R01AA011855 ( U.S. NIH Grant/Contract )
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: May 14, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents