Nctid:
NCT00000303
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D019970", "term"=>"Cocaine-Related Disorders"}], "ancestors"=>[{"id"=>"D019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M21841", "name"=>"Cocaine-Related Disorders", "asFound"=>"Cocaine-Related Disorders", "relevance"=>"HIGH"}, {"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"=>"D001418", "term"=>"Baclofen"}], "ancestors"=>[{"id"=>"D009125", "term"=>"Muscle Relaxants, Central"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D009465", "term"=>"Neuromuscular Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D058786", "term"=>"GABA-B Receptor Agonists"}, {"id"=>"D018755", "term"=>"GABA Agonists"}, {"id"=>"D018682", "term"=>"GABA Agents"}, {"id"=>"D018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M4716", "name"=>"Baclofen", "asFound"=>"Diffusion", "relevance"=>"HIGH"}, {"id"=>"M6271", "name"=>"Cocaine", "relevance"=>"LOW"}, {"id"=>"M20825", "name"=>"GABA Agonists", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Muscle Relaxants, Central", "abbrev"=>"MuRelCen"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>0}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-10"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2016-07", "lastUpdateSubmitDate"=>"2016-07-07", "studyFirstSubmitDate"=>"1999-09-20", "studyFirstSubmitQcDate"=>"1999-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2016-07-11", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-21", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1999-05", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Retention"}, {"measure"=>"Cocaine use"}, {"measure"=>"Cocaine craving"}, {"measure"=>"Psychosocial progress"}]}, "conditionsModule"=>{"keywords"=>["Cocaine dependence"], "conditions"=>["Cocaine-Related Disorders"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to empirically test a series of medications to: 1) determine each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective dose range for each medication. In this study, baclofen is tested.", "detailedDescription"=>"16-week participation plus a 2 week lead in period. Participants are assigned randomly to placebo or baclofen. Participant attend group meetings 3 x/week."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nM/F ages 18-65. cocaine dependence according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (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, dependence on ethanol (ETOH) or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe."}, "identificationModule"=>{"nctId"=>"NCT00000303", "briefTitle"=>"Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6", "organization"=>{"class"=>"OTHER", "fullName"=>"University of California, Los Angeles"}, "officialTitle"=>"Rapid Evaluation of Cocaine Pharmacotherapies (Baclofen)", "orgStudyIdInfo"=>{"id"=>"NIDA-09260-6"}, "secondaryIdInfos"=>[{"id"=>"P50DA009260", "link"=>"https://reporter.nih.gov/quickSearch/P50DA009260", "type"=>"NIH"}, {"id"=>"P50-09260-6"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Baclofen", "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"=>"University of California, Los Angeles", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
