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Trial NCT00000452

Resource URI: http://static.linkedct.org/resource/trials/NCT00000452
linkedct:brief_title Naltrexone Treatment of Alcohol Dependence
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - Meets criteria for current diagnosis of alcohol dependence. - Subjects used more than 15 standard alcohol drinks (average)/week with at least 1 day of 5 or more drinks in the past 30 days. - Successful completion of medical detoxification. - Lives within a commutable distance to the Treatment Research Center and agrees to follow-up visits. - Understands and signs the informed consent. Exclusion Criteria: - Current diagnosis of any substance dependence other than alcohol, nicotine, or marijuana. - Evidence of opiate use in the past 30 days. - Current treatment with psychotropic medications, including disulfiram (Antabuse) (excluding short-term use of benzodiazepines for detoxification). - History of unstable or serious medical illness, including need for opioid analgesics. - Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels, and current severe psychiatric symptoms. - Use of an investigation medication in the past 30 days. - Female subjects who are pregnant, nursing, or not using reliable method of contraception.
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 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date January 2003
linkedct:enrollment 240 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000452
rdfs:label Trial NCT00000452
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/160150>
linkedct:nct_id NCT00000452
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NIAAAVOL07517
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000452>
linkedct:phase Phase 4
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
linkedct:study_type Interventional
linkedct:summary The long-range goal of this ongoing research program is to find more effective treatments for alcohol dependence by combining medication with the appropriate psychosocial support. This proposal has three specific aims: (1) to compare the effectiveness of naltrexone (Revia) in three types of treatment settings; (2) to assess the effects of psychosocial support on medication compliance and treatment retention; and (3) to investigate the individual characteristics that may predict who is likely to benefit from additional psychosocial support versus simple medication management.
rdf:type linkedct:trials
linkedct:verification_date November 2004