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Trial NCT00000302

Resource URI: http://static.linkedct.org/resource/trials/NCT00000302
PropertyValue
linkedct:brief_title Study Comparing Liquid and Tablet Buprenorphine Formulations - 5
linkedct:condition <http://static.linkedct.org/resource/condition/5932>
linkedct:criteria Inclusion Criteria: M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
linkedct:description Participants were inducted on either liquid or tablet buprenorphine, in a double-blind, double-dummy manner. They each reached a steady state by the second week, and were scheduled to have blood draws in weeks 3, 4, 7, 8, 11, 12, 15, and 16.
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 50 Years
linkedct:eligibility_minimum_age 21 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 20, 1999
linkedct:id NCT00000302
rdfs:label Trial NCT00000302
linkedct:lastchanged_date November 3, 2005
linkedct:lead_sponsor_agency National Institute on Drug Abuse (NIDA)
linkedct:location <http://static.linkedct.org/resource/location/209856>
linkedct:nct_id NCT00000302
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Expanded Steady-State Pharmacokinetic Study, Comparing Liquid and Tablet Buprenorphine Formulations
linkedct:org_study_id NIDA-09260-5
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/60742>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000302>
linkedct:phase Phase 3
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/19100>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7275>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7287>
linkedct:secondary_id P50-09260-5
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:study_design Treatment, Double-Blind
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to compare liquid and tablet buprenorphine formulations.
rdf:type linkedct:trials
linkedct:verification_date December 2002