Nctid:
NCT00000306
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009293", "term"=>"Opioid-Related Disorders"}, {"id"=>"D000019970", "term"=>"Cocaine-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"=>"M21841", "name"=>"Cocaine-Related Disorders", "asFound"=>"Cocaine-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"=>"D000003913", "term"=>"Dextroamphetamine"}], "ancestors"=>[{"id"=>"D000000697", "term"=>"Central Nervous System Stimulants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018765", "term"=>"Dopamine Uptake Inhibitors"}, {"id"=>"D000014179", "term"=>"Neurotransmitter Uptake Inhibitors"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000015259", "term"=>"Dopamine Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}], "browseLeaves"=>[{"id"=>"M27371", "name"=>"Opiate Alkaloids", "relevance"=>"LOW"}, {"id"=>"M6271", "name"=>"Cocaine", "relevance"=>"LOW"}, {"id"=>"M7108", "name"=>"Dextroamphetamine", "asFound"=>"Xeomin", "relevance"=>"HIGH"}, {"id"=>"M4029", "name"=>"Central Nervous System Stimulants", "relevance"=>"LOW"}, {"id"=>"M7473", "name"=>"Dopamine", "relevance"=>"LOW"}, {"id"=>"M20832", "name"=>"Dopamine Uptake Inhibitors", "relevance"=>"LOW"}, {"id"=>"M17962", "name"=>"Dopamine Agents", "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"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"Central Nervous System Stimulants", "abbrev"=>"CNSSti"}, {"name"=>"Cardiotonic Agents", "abbrev"=>"CaAg"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"count"=>140}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2016-10", "completionDateStruct"=>{"date"=>"2001-09"}, "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"=>"Craving"}, {"measure"=>"Drug use"}, {"measure"=>"Medication compliance"}, {"measure"=>"Retention"}, {"measure"=>"Addiction severity"}, {"measure"=>"Mood indicators"}, {"measure"=>"Psychiatric interview"}], "secondaryOutcomes"=>[{"measure"=>"Effectiveness measures including psycho-social variables, side effects, and self-reported measures."}]}, "conditionsModule"=>{"keywords"=>["cocaine dependence"], "conditions"=>["Cocaine-Related Disorders", "Opioid-Related Disorders"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.", "detailedDescription"=>"This 27-week double-blind, placebo controlled treatment is designed to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients. All subjects will receive methadone. For the treatment of cocaine dependence, subjects will receive one of 2 doses of dextroamphetamine (15 or 30mg) or placebo. After 4 weeks of treatment the dose level of dextroamphetamine is doubled (30 or 60mg). This dose is maintained for 20 weeks; during which subjects attend twice weekly visits to the clinic and receive weekly cognitive behavioral therapy. Follow up evaluations will be conducted out to 3 months post treatment. Subjects will be assisted in transferring to Houston area methadone clinics to maintain treatment for opiate dependence following treatment completion."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"45 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria- Subject must:\n\n* Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID.\n* Be between 18 and 45 years old\n* Women must agree to use contraception\n* Have an EKG that has been confirmed by a cardiologist\n* Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal\n\nExclusion Criteria- Subject must not:\n\n• Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent\n\n* Have any Axis I disorder that is not related to drug use\n* Have current dependence on any psychoactive disorder other than nicotine\n* Be on probation or parole for reasons other than those related to drug charges (ASI)\n* Be pregnant or lactating\n* Have been in any outside treatment in 3 months"}, "identificationModule"=>{"nctId"=>"NCT00000306", "briefTitle"=>"Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Drug Abuse (NIDA)"}, "officialTitle"=>"Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients", "orgStudyIdInfo"=>{"id"=>"NIDA-09262-3"}, "secondaryIdInfos"=>[{"id"=>"P50-09262-3"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Dextroamphetamine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"77225", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"University of Texas Health Science Center", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}], "overallOfficials"=>[{"name"=>"John Grabowski, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Texas"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Drug Abuse (NIDA)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"University of Texas", "class"=>"OTHER"}]}}}