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Trial NCT00000450

Resource URI: http://static.linkedct.org/resource/trials/NCT00000450
linkedct:brief_title Naltrexone Maintenance Treatment of Alcoholism
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct:criteria Inclusion Criteria: - Meets criteria for alcohol dependence. - Expresses a desire to cut down or stop drinking. Exclusion Criteria: - Currently meets criteria for dependence on substances other than alcohol. - History of opiate dependence or evidence of current opiate use. - Significant medical disorders that will increase potential risk or interfere with study participation. - Liver function tests more than 3 times normal or elevated bilirubin. - Female patients who are pregnant, nursing, or not using a reliable method of birth control. - Inability to understand and provide a consent form. - Treatment with an investigational drug during the previous month. - Prior treatment with naltrexone. - Chronic treatment with any narcotic-containing medications during the previous month. - Sensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists. - Current treatment with disulfiram. - More than 6 weeks of abstinence. - Meets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy.
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 65 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date April 2002
linkedct:enrollment 184 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000450
rdfs:label Trial NCT00000450
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/173597>
linkedct:nct_id NCT00000450
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Nalmefene Maintenance Treatment of Alcoholism
linkedct:org_study_id NIAAAMAS10518
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000450>
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 purpose of this study is to determine the long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. Those who respond to short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup.
rdf:type linkedct:trials
linkedct:verification_date August 2002