Nctid:
NCT00000329
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009293", "term"=>"Opioid-Related Disorders"}, {"id"=>"D000006556", "term"=>"Heroin Dependence"}], "ancestors"=>[{"id"=>"D000079524", "term"=>"Narcotic-Related Disorders"}, {"id"=>"D000019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D000001523", "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"=>"D000000701", "term"=>"Analgesics, Opioid"}], "ancestors"=>[{"id"=>"D000009294", "term"=>"Narcotics"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}], "browseLeaves"=>[{"id"=>"M4033", "name"=>"Analgesics, Opioid", "asFound"=>"Iron", "relevance"=>"HIGH"}, {"id"=>"M5317", "name"=>"Buprenorphine", "relevance"=>"LOW"}, {"id"=>"M12221", "name"=>"Naloxone", "relevance"=>"LOW"}, {"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"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Narcotic Antagonists", "abbrev"=>"NarcAntag"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>0}}, "statusModule"=>{"overallStatus"=>"WITHDRAWN", "startDateStruct"=>{"date"=>"1999-04"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2017-05", "completionDateStruct"=>{"date"=>"1999-08", "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"=>"1999-08", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Subjective dose estimate"}, {"measure"=>"Observed withdrawal rating"}, {"measure"=>"Opioid agonist rating"}, {"measure"=>"Opioid antagonist rating"}, {"measure"=>"Pupil diameter"}, {"measure"=>"Analog rating scale for drug effects"}, {"measure"=>"Drug effect characteristics"}, {"measure"=>"Drug/Money Preferences"}]}, "conditionsModule"=>{"keywords"=>["drug dependence"], "conditions"=>["Heroin Dependence", "Opioid-Related Disorders"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in buprenorphine-naloxone maintained volunteers", "detailedDescription"=>"Ongoing study - results not available at this time"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nIndividuals must be at least 18 yrs of age, 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 and have a history of IV opioid use.\n\nExclusion Criteria:\n\nIndividuals with evidence of anti 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"=>"NCT00000329", "briefTitle"=>"Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Colorado, Denver"}, "officialTitle"=>"Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1", "orgStudyIdInfo"=>{"id"=>"NIDA-11160-4"}, "secondaryIdInfos"=>[{"id"=>"R01DA011160", "link"=>"https://reporter.nih.gov/quickSearch/R01DA011160", "type"=>"NIH"}, {"id"=>"R01-11160-4"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Opioid-Related Disorders", "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"}}}}
