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Naltrexone Treatment for 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: 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

MedlinePlus related topics:   Alcoholism   

Drug Information available for:   Naltrexone    Naltrexone hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Placebo Control, Efficacy Study
Official Title:   Naltrexone Treatment for Alcoholism: Predicting Outcome

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

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
  More Information


Study ID Numbers:   NIAAAMCC11855
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000438
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

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 December 03, 2008




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