Nctid:
NCT00000326
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009293", "term"=>"Opioid-Related Disorders"}, {"id"=>"D006556", "term"=>"Heroin Dependence"}], "ancestors"=>[{"id"=>"D000079524", "term"=>"Narcotic-Related Disorders"}, {"id"=>"D019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M12244", "name"=>"Opioid-Related Disorders", "asFound"=>"Opioid-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M9634", "name"=>"Heroin Dependence", "asFound"=>"Heroin Dependence", "relevance"=>"HIGH"}, {"id"=>"M2057", "name"=>"Narcotic-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D003932", "term"=>"Heroin"}], "ancestors"=>[{"id"=>"D000701", "term"=>"Analgesics, Opioid"}, {"id"=>"D009294", "term"=>"Narcotics"}, {"id"=>"D002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}], "browseLeaves"=>[{"id"=>"M5317", "name"=>"Buprenorphine", "relevance"=>"LOW"}, {"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M12221", "name"=>"Naloxone", "relevance"=>"LOW"}, {"id"=>"M7127", "name"=>"Heroin", "asFound"=>"Carotid Revascularization", "relevance"=>"HIGH"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Narcotic Antagonists", "abbrev"=>"NarcAntag"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>0}}, "statusModule"=>{"overallStatus"=>"WITHDRAWN", "startDateStruct"=>{"date"=>"1997-04"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2017-05", "completionDateStruct"=>{"date"=>"1997-08", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2017-05-02", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2017-05-04", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1997-08", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Drug use"}, {"measure"=>"Retention"}, {"measure"=>"Subjective dose estimate"}, {"measure"=>"Observed withdrawal rating"}, {"measure"=>"Opioid agonist rating"}, {"measure"=>"Opioid antagonist rating"}, {"measure"=>"Pupil diameter"}, {"measure"=>"Compliance"}, {"measure"=>"Analog rating scale for drug effects"}, {"measure"=>"Drug effect characteristics"}, {"measure"=>"Dose order estimate-nurse"}, {"measure"=>"Dose order estimate-client"}]}, "conditionsModule"=>{"keywords"=>["Heroin Dependence"], "conditions"=>["Heroin Dependence", "Opioid-Related Disorders"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"(presented at ACNP 1997. Kamien, J.B., Mikulich, S.K., and Amass, L., Efficacy of the buprenorphine/naloxone tablet for daily vs. alternate-day opioid dependence treatment. Presented to the 1998 Meeting of the College on Problems of Drug Dependence.. Presented at ACNP 1997 and CPDD 1998."}]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"64 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nIndividuals 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.\n\nExclusion Criteria:\n\nIndividuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (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."}, "identificationModule"=>{"nctId"=>"NCT00000326", "briefTitle"=>"Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Colorado, Denver"}, "officialTitle"=>"Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)", "orgStudyIdInfo"=>{"id"=>"NIDA-11160-1"}, "secondaryIdInfos"=>[{"id"=>"1R01DA011160", "link"=>"https://reporter.nih.gov/quickSearch/1R01DA011160", "type"=>"NIH"}, {"id"=>"R01-11160-1"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Heroin Dependence", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"80206", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"University of Colorado Health Sciences Center", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}], "overallOfficials"=>[{"name"=>"Leslie Amass, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Colorado, Denver"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Colorado, Denver", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
