Nctid:
NCT00000345
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009293", "term"=>"Opioid-Related Disorders"}], "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"=>"M2057", "name"=>"Narcotic-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic 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"=>"C000025655", "term"=>"Lofexidine"}], "ancestors"=>[{"id"=>"D000000959", "term"=>"Antihypertensive Agents"}, {"id"=>"D000009292", "term"=>"Narcotic Antagonists"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000058647", "term"=>"Adrenergic alpha-2 Receptor Agonists"}, {"id"=>"D000000316", "term"=>"Adrenergic alpha-Agonists"}, {"id"=>"D000000322", "term"=>"Adrenergic Agonists"}, {"id"=>"D000018663", "term"=>"Adrenergic Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M27371", "name"=>"Opiate Alkaloids", "relevance"=>"LOW"}, {"id"=>"M289447", "name"=>"Lofexidine", "asFound"=>"DTaP-", "relevance"=>"HIGH"}, {"id"=>"M4277", "name"=>"Antihypertensive Agents", "relevance"=>"LOW"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M12243", "name"=>"Narcotic Antagonists", "relevance"=>"LOW"}, {"id"=>"M20746", "name"=>"Adrenergic Agents", "relevance"=>"LOW"}, {"id"=>"M3668", "name"=>"Adrenergic alpha-Agonists", "relevance"=>"LOW"}, {"id"=>"M3673", "name"=>"Adrenergic Agonists", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antihypertensive Agents", "abbrev"=>"AnAg"}, {"name"=>"Narcotic Antagonists", "abbrev"=>"NarcAntag"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>0}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-04"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1997-09", "lastUpdateSubmitDate"=>"2017-01-11", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2017-01-12", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Opiate withdrawal"}, {"measure"=>"Adverse effect measures"}, {"measure"=>"Craving of opiates"}, {"measure"=>"Liking of opiates"}, {"measure"=>"Efficacy of lofexidine"}, {"measure"=>"Euphoria"}]}, "conditionsModule"=>{"keywords"=>["opioid dependence"], "conditions"=>["Opioid-Related Disorders"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to assess the safety of lofexidine in the treatment of opiate-dependent individuals."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nM/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.\n\nExclusion Criteria:\n\nPsychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe."}, "identificationModule"=>{"nctId"=>"NCT00000345", "briefTitle"=>"Evaluation of Lofexidine for Treatment of Opiate Withdrawal - 10", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Drug Abuse (NIDA)"}, "officialTitle"=>"Evaluation of Lofexidine for Treatment of Opiate Withdrawal", "orgStudyIdInfo"=>{"id"=>"NIDA-3-0010-10"}, "secondaryIdInfos"=>[{"id"=>"Y01-3-0010-10"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Lofexidine", "type"=>"DRUG"}]}, "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"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}}}}