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Naltrexone Treatment for Alcoholism - Article


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Clinical Trial: 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)

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 Treatment or Intervention Phase
Alcoholism
 Drug: naltrexone (Revia)
Phase IV

MedlinePlus related topics:  Alcoholism

Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control, Efficacy Study

Official Title: Naltrexone Treatment for Alcoholism: Predicting Outcome

Further Study Details: 

Expected Total Enrollment:  192

Study completion: March 2003

Eligibility

Ages Eligible for Study:  30 Years   -   55 Years,  Genders Eligible for Study:  Both

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.

Location Information


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

More Information

Study ID Numbers:  NIAAAMCC11855
Record last reviewed:  November 2004
Last Updated:  November 22, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000438
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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