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Trial NCT00000326

Resource URI: http://static.linkedct.org/resource/trials/NCT00000326
PropertyValue
linkedct:brief_title Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1
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: Individuals must be currently opioid 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 Alternate-day dosing with the 8mg buprenorhpine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided druing alternate-day dosing is equal to that given during daily dosing.
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 64 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 20, 1999
linkedct:id NCT00000326
rdfs:label Trial NCT00000326
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 NCT00000326
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)
linkedct:org_study_id NIDA-11160-1
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/NCT00000326>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/14202>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/14372>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/14374>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/17569>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/1803>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/19100>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/20857>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/5443>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7166>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7167>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7277>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7287>
linkedct:reference <http://static.linkedct.org/resource/reference/26>
linkedct:secondary_id R01-11160-1
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:start_date April 1997
linkedct:study_design Treatment, Double-Blind, Placebo Control, Crossover Assignment
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
rdf:type linkedct:trials
linkedct:verification_date August 1997