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Naltrexone Treatment for Alcoholism



Naltrexone Treatment for Alcoholism

For Condition: Alcoholism
Status: Completed
Sponsor(s): National Institute on Alcohol Abuse and Alcoholism (NIAAA) ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 30 Years/55 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 192

Location and Contact Information:

Johns Hopkins Hospital
Baltimore,  Maryland,  21205
United States
 


Additional Information:
Study ID Numbers:
  NIAAAMCC11855; 
Study Start Date: 
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000438

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5. COMBINE (acamprosate/naltrexone)

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