Naltrexone Treatment for Alcoholism

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00000438
First received: November 2, 1999
Last updated: May 13, 2010
Last verified: May 2010
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  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 July 29, 2014