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Trial NCT00000438

Resource URI: http://static.linkedct.org/resource/trials/NCT00000438
linkedct:brief_title Naltrexone Treatment for Alcoholism
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 55 Years
linkedct:eligibility_minimum_age 30 Years
linkedct:end_date March 2003
linkedct:enrollment 192 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000438
rdfs:label Trial NCT00000438
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/163037>
linkedct:nct_id NCT00000438
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Naltrexone Treatment for Alcoholism: Predicting Outcome
linkedct:org_study_id NIAAAMCC11855
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000438>
linkedct:phase Phase 4
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:study_design Treatment, Randomized, Placebo Control, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date November 2004