Nctid:
NCT00000331
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"=>{"browseLeaves"=>[{"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M5317", "name"=>"Buprenorphine", "relevance"=>"LOW"}, {"id"=>"M12221", "name"=>"Naloxone", "relevance"=>"LOW"}, {"id"=>"M7127", "name"=>"Heroin", "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"WITHDRAWN", "startDateStruct"=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"=>"2002-12"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2017-05", "completionDateStruct"=>{"date"=>"2002-12", "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"=>"2002-12", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Observed withdrawal rating"}, {"measure"=>"Pupil diameter"}, {"measure"=>"Drug effect characteristics"}]}, "conditionsModule"=>{"keywords"=>["Heroin 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 healthy, non-drug dependent volunteers.", "detailedDescription"=>"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 healthy, non-drug dependent volunteers, be at least 18 years of age, and have no prior history of drug or alcohol abuse or dependence. Subjects must have had some minimal experience with opioids (e.g. at least two prior exposures)\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"=>"NCT00000331", "briefTitle"=>"Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3 - 6", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Colorado, Denver"}, "officialTitle"=>"Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3", "orgStudyIdInfo"=>{"id"=>"NIDA-11160-6"}, "secondaryIdInfos"=>[{"id"=>"R01DA011160", "link"=>"https://reporter.nih.gov/quickSearch/R01DA011160", "type"=>"NIH"}, {"id"=>"R01-11160-6"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Test Drug", "description"=>"Test drug to prevent heroine withdrawal", "interventionNames"=>["Drug: Test Drug"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo Pill", "description"=>"Placebo drug", "interventionNames"=>["Drug: Placebo Drug"]}], "interventions"=>[{"name"=>"Test Drug", "type"=>"DRUG", "otherNames"=>["test drug o"], "armGroupLabels"=>["Test Drug"]}, {"name"=>"Placebo Drug", "type"=>"DRUG", "armGroupLabels"=>["Placebo Pill"]}]}, "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"}}}}
