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Trial NCT00000327

Resource URI: http://static.linkedct.org/resource/trials/NCT00000327
PropertyValue
linkedct:brief_title Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8711>
linkedct:condition <http://static.linkedct.org/resource/condition/5932>
linkedct:condition <http://static.linkedct.org/resource/condition/9249>
linkedct:criteria Inclusion Criteria: Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active DSM-IV Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
linkedct:description Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tabelt (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic
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 62 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 20, 1999
linkedct:id NCT00000327
rdfs:label Trial NCT00000327
linkedct:lastchanged_date November 3, 2005
linkedct:lead_sponsor_agency National Institute on Drug Abuse (NIDA)
linkedct:location <http://static.linkedct.org/resource/location/205451>
linkedct:nct_id NCT00000327
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2)
linkedct:org_study_id NIDA-11160-2
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/35001>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000327>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/1802>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/19100>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/5443>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7244>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7287>
linkedct:reference <http://static.linkedct.org/resource/reference/205>
linkedct:secondary_id R01-11160-2
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:start_date June 1997
linkedct:study_design Treatment, Double-Blind, Crossover Assignment
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.
rdf:type linkedct:trials
linkedct:verification_date November 1997