Nctid:
NCT00000299
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009293", "term"=>"Opioid-Related Disorders"}], "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"=>"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"=>"D002047", "term"=>"Buprenorphine"}], "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"}, {"id"=>"D009292", "term"=>"Narcotic Antagonists"}], "browseLeaves"=>[{"id"=>"M5317", "name"=>"Buprenorphine", "asFound"=>"Group B", "relevance"=>"HIGH"}, {"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M12221", "name"=>"Naloxone", "relevance"=>"LOW"}, {"id"=>"M12222", "name"=>"Naltrexone", "relevance"=>"LOW"}, {"id"=>"M27371", "name"=>"Opiate Alkaloids", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M12243", "name"=>"Narcotic Antagonists", "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"}, {"name"=>"Alcohol Deterrents", "abbrev"=>"AlcDet"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>12}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2008-10"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2016-01", "completionDateStruct"=>{"date"=>"2009-11", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2016-01-27", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2016-01-29", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2009-11", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Opiate craving", "timeFrame"=>"10 test days", "description"=>"opiate craving is measured on each test day."}, {"measure"=>"Opiate withdrawal symptoms", "timeFrame"=>"10 test days", "description"=>"opiate withdrawal symptoms are documented for each test day"}]}, "conditionsModule"=>{"keywords"=>["Opioid-Related Disorders"], "conditions"=>["Opioid-Related Disorders"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to develop a clinical protocol to detoxify patients from opiates to naltrexone using buprenorphine and to develop pilot data for a grant application for a controlled study of the efficacy of the new clinical protocol for outpatients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nMales/Females, ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.\n\nExclusion Criteria:\n\npsychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependent on etoh or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe."}, "identificationModule"=>{"nctId"=>"NCT00000299", "briefTitle"=>"Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2", "organization"=>{"class"=>"OTHER", "fullName"=>"University of California, Los Angeles"}, "officialTitle"=>"Rapid Opiate Detoxification & Naltrexone Induction Using Bup.", "orgStudyIdInfo"=>{"id"=>"NIDA-09260-2"}, "secondaryIdInfos"=>[{"id"=>"P50DA009260", "link"=>"https://reporter.nih.gov/quickSearch/P50DA009260", "type"=>"NIH"}, {"id"=>"P50-09260-2"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"buprenorphine", "description"=>"depot buprenorphine", "interventionNames"=>["Drug: Buprenorphine"]}, {"type"=>"EXPERIMENTAL", "label"=>"buprenorphine and ultra-low dose naloxone", "description"=>"depot buprenorphine and naloxone", "interventionNames"=>["Drug: Buprenorphine"]}], "interventions"=>[{"name"=>"Buprenorphine", "type"=>"DRUG", "armGroupLabels"=>["buprenorphine", "buprenorphine and ultra-low dose naloxone"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90025", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Friends Research Institute", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}], "overallOfficials"=>[{"name"=>"Walter Ling, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Friends Research Institute, Inc."}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of California, Los Angeles", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"PI", "investigatorFullName"=>"Walter Ling", "investigatorAffiliation"=>"University of California, Los Angeles"}}}}
