Nctid:
NCT00000273
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D000009293", "term"=>"Opioid-Related Disorders"}, {"id"=>"D000006556", "term"=>"Heroin Dependence"}], "ancestors"=>[{"id"=>"D000064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000079524", "term"=>"Narcotic-Related Disorders"}], "browseLeaves"=>[{"id"=>"M12244", "name"=>"Opioid-Related Disorders", "asFound"=>"Opioid-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "asFound"=>"Substance-Related Disorders", "relevance"=>"HIGH"}, {"id"=>"M9634", "name"=>"Heroin Dependence", "asFound"=>"Heroin Dependence", "relevance"=>"HIGH"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M2057", "name"=>"Narcotic-Related 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"=>"D000005283", "term"=>"Fentanyl"}, {"id"=>"D000009020", "term"=>"Morphine"}, {"id"=>"D000010098", "term"=>"Oxycodone"}, {"id"=>"D000002047", "term"=>"Buprenorphine"}, {"id"=>"D000008691", "term"=>"Methadone"}], "ancestors"=>[{"id"=>"D000000701", "term"=>"Analgesics, Opioid"}, {"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"}, {"id"=>"D000000759", "term"=>"Adjuvants, Anesthesia"}, {"id"=>"D000018686", "term"=>"Anesthetics, Intravenous"}, {"id"=>"D000018681", "term"=>"Anesthetics, General"}, {"id"=>"D000000777", "term"=>"Anesthetics"}, {"id"=>"D000009292", "term"=>"Narcotic Antagonists"}, {"id"=>"D000000996", "term"=>"Antitussive Agents"}, {"id"=>"D000019141", "term"=>"Respiratory System Agents"}], "browseLeaves"=>[{"id"=>"M8418", "name"=>"Fentanyl", "asFound"=>"Diagnosis", "relevance"=>"HIGH"}, {"id"=>"M11671", "name"=>"Methadone", "asFound"=>"1 dose", "relevance"=>"HIGH"}, {"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M5317", "name"=>"Buprenorphine", "asFound"=>"Childhood", "relevance"=>"HIGH"}, {"id"=>"M11982", "name"=>"Morphine", "asFound"=>"400", "relevance"=>"HIGH"}, {"id"=>"M27371", "name"=>"Opiate Alkaloids", "relevance"=>"LOW"}, {"id"=>"M13020", "name"=>"Oxycodone", "asFound"=>"Consist", "relevance"=>"HIGH"}, {"id"=>"M7127", "name"=>"Heroin", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M4089", "name"=>"Adjuvants, Anesthesia", "relevance"=>"LOW"}, {"id"=>"M20766", "name"=>"Anesthetics, Intravenous", "relevance"=>"LOW"}, {"id"=>"M20761", "name"=>"Anesthetics, General", "relevance"=>"LOW"}, {"id"=>"M12243", "name"=>"Narcotic Antagonists", "relevance"=>"LOW"}, {"id"=>"M13570", "name"=>"Phenylpropanolamine", "relevance"=>"LOW"}, {"id"=>"M9238", "name"=>"Guaifenesin", "relevance"=>"LOW"}, {"id"=>"M186319", "name"=>"Chlorpheniramine, phenylpropanolamine drug combination", "relevance"=>"LOW"}, {"id"=>"M4312", "name"=>"Antitussive Agents", "relevance"=>"LOW"}, {"id"=>"M21137", "name"=>"Respiratory System Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Adjuvants, Anesthesia", "abbrev"=>"AdjAn"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antitussive Agents", "abbrev"=>"AnTuAg"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}, {"name"=>"Narcotic Antagonists", "abbrev"=>"NarcAntag"}, {"name"=>"Anti-Obesity Agents", "abbrev"=>"AnObAg"}, {"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>8}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-08"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2017-06", "completionDateStruct"=>{"date"=>"2005-11", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2017-07-03", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2017-07-05", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2005-11", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Amount drug self-administered", "timeFrame"=>"90 minutes", "description"=>"All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order. Participants were instructed to choose between the dose that they had received during the sample session or another reward.."}], "secondaryOutcomes"=>[{"measure"=>"Subjective responses", "timeFrame"=>"90 min", "description"=>"Four questionnaires were used to assess subjective effects"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["heroin, opioid disorders, substance related disorders"], "conditions"=>["Heroin Dependence", "Opioid-Related Disorders", "Substance-Related Disorders"]}, "referencesModule"=>{"references"=>[{"pmid"=>"17581533", "type"=>"RESULT", "citation"=>"Comer SD, Sullivan MA, Whittington RA, Vosburg SK, Kowalczyk WJ. Abuse liability of prescription opioids compared to heroin in morphine-maintained heroin abusers. Neuropsychopharmacology. 2008 Apr;33(5):1179-91. doi: 10.1038/sj.npp.1301479. Epub 2007 Jun 20."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration.\"", "detailedDescription"=>"Abuse of prescription opioid medications has increased dramatically in the U.S. during the past decade, as indicated by a variety of epidemiological sources. However, few studies have systematically examined the relative reinforcing effects of commonly abused opioid medications. The current inpatient study was designed to compare the effects of intravenously delivered fentanyl , oxycodone, morphine, buprenorphine and heroin in morphine-maintained heroin abusers. All of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"45 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criterion\n\n1. DSM IV criteria for opioid dependence\n2. No major mood, psychotic, or anxiety disorder\n3. Physically healthy\n4. Able to perform study procedures\n5. 21-45 years of age\n6. Current use of i.v. heroin in amounts/frequencies\n7. Not seeking treatment for opioid dependence\n\nExclusion Criterion\n\n1. DSM IV criteria for dependence on drugs other\n2. Participants requesting treatment\n3. Participants on parole or probation\n4. Pregnancy or lactation\n5. Birth, miscarriage or abortion with 6 months\n6. Recent history of or current significant violent behavior\n7. Current major Axis I psychopathology, other than heroin dependence ( e.g., mood disorder with functional impairment or suicide risk, schizophrenia), which might interfere with ability to participate in the study\n8. Hepatitis with SGOT or SGPT \\> 3 times normal\n9. Significant suicide risk\n10. Current or history of chronic pain\n11. Sensitivity, allergy, or contraindication to opioids"}, "identificationModule"=>{"nctId"=>"NCT00000273", "briefTitle"=>"A Laboratory Model for Heroin Abuse Medications - 8", "organization"=>{"class"=>"OTHER", "fullName"=>"New York State Psychiatric Institute"}, "officialTitle"=>"A Laboratory Model for Heroin Abuse Medications", "orgStudyIdInfo"=>{"id"=>"#4857/5982R"}, "secondaryIdInfos"=>[{"id"=>"5P50DA009236-18", "link"=>"https://reporter.nih.gov/quickSearch/5P50DA009236-18", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Opiates", "description"=>"Opiate-dependent individuals who were currently not seeking treatment for their drug use, completed the 6-week protocol.", "interventionNames"=>["Drug: opiates"]}], "interventions"=>[{"name"=>"opiates", "type"=>"DRUG", "otherNames"=>["morphine", "fentanyl", "buprenorphine", "oxycodone", "methadone"], "description"=>"prescription opioids", "armGroupLabels"=>["Opiates"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia University", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"New York State Psychiatric Institute", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}], "overallOfficials"=>[{"name"=>"Herbert Kleber, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"New York State Psychiatric Institute"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"New York State Psychiatric Institute", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
