Nctid:
NCT00000317
Payload:
{"FullStudy"=>{"Rank"=>499005, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000019966", "ConditionMeshTerm"=>"Substance-Related Disorders"}, {"ConditionMeshId"=>"D000019970", "ConditionMeshTerm"=>"Cocaine-Related Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000064419", "ConditionAncestorTerm"=>"Chemically-Induced Disorders"}, {"ConditionAncestorId"=>"D000001523", "ConditionAncestorTerm"=>"Mental Disorders"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M21837", "ConditionBrowseLeafName"=>"Substance-Related Disorders", "ConditionBrowseLeafAsFound"=>"Substance-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21841", "ConditionBrowseLeafName"=>"Cocaine-Related Disorders", "ConditionBrowseLeafAsFound"=>"Cocaine-Related Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M30302", "ConditionBrowseLeafName"=>"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4815", "ConditionBrowseLeafName"=>"Mental Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14473", "ConditionBrowseLeafName"=>"Psychotic Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Substance Related Disorders", "ConditionBrowseBranchAbbrev"=>"BC25"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000018967", "InterventionMeshTerm"=>"Risperidone"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000012702", "InterventionAncestorTerm"=>"Serotonin Antagonists"}, {"InterventionAncestorId"=>"D000018490", "InterventionAncestorTerm"=>"Serotonin Agents"}, {"InterventionAncestorId"=>"D000018377", "InterventionAncestorTerm"=>"Neurotransmitter Agents"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000014150", "InterventionAncestorTerm"=>"Antipsychotic Agents"}, {"InterventionAncestorId"=>"D000014149", "InterventionAncestorTerm"=>"Tranquilizing Agents"}, {"InterventionAncestorId"=>"D000002492", "InterventionAncestorTerm"=>"Central Nervous System Depressants"}, {"InterventionAncestorId"=>"D000011619", "InterventionAncestorTerm"=>"Psychotropic Drugs"}, {"InterventionAncestorId"=>"D000018492", "InterventionAncestorTerm"=>"Dopamine Antagonists"}, {"InterventionAncestorId"=>"D000015259", "InterventionAncestorTerm"=>"Dopamine Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M11671", "InterventionBrowseLeafName"=>"Methadone", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20999", "InterventionBrowseLeafName"=>"Risperidone", "InterventionBrowseLeafAsFound"=>"Added", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M6271", "InterventionBrowseLeafName"=>"Cocaine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M15512", "InterventionBrowseLeafName"=>"Serotonin", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20504", "InterventionBrowseLeafName"=>"Neurotransmitter Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16904", "InterventionBrowseLeafName"=>"Antipsychotic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14474", "InterventionBrowseLeafName"=>"Psychotropic Drugs", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7473", "InterventionBrowseLeafName"=>"Dopamine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20596", "InterventionBrowseLeafName"=>"Dopamine Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M17962", "InterventionBrowseLeafName"=>"Dopamine Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Analgesics", "InterventionBrowseBranchAbbrev"=>"Analg"}, {"InterventionBrowseBranchName"=>"Antitussive Agents", "InterventionBrowseBranchAbbrev"=>"AnTuAg"}, {"InterventionBrowseBranchName"=>"Central Nervous System Depressants", "InterventionBrowseBranchAbbrev"=>"CNSDep"}, {"InterventionBrowseBranchName"=>"Respiratory System Agents", "InterventionBrowseBranchAbbrev"=>"Resp"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Psychotropic Drugs", "InterventionBrowseBranchAbbrev"=>"PsychDr"}, {"InterventionBrowseBranchName"=>"Vasoconstrictor Agents", "InterventionBrowseBranchAbbrev"=>"VaCoAg"}, {"InterventionBrowseBranchName"=>"Cardiotonic Agents", "InterventionBrowseBranchAbbrev"=>"CaAg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double", "DesignWhoMaskedList"=>{"DesignWhoMasked"=>["Participant", "Investigator"]}}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Crossover Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"31"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"August 1996", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"June 2017", "CompletionDateStruct"=>{"CompletionDate"=>"July 1999", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"June 22, 2017", "StudyFirstSubmitDate"=>"September 20, 1999", "StudyFirstSubmitQCDate"=>"September 20, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"June 26, 2017", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"September 21, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"July 1999", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Side effects", "PrimaryOutcomeTimeFrame"=>"1x/week for 18 weeks", "PrimaryOutcomeDescription"=>"Using the Modified Systemic Assessment for Treatment Emergent Effects the psychiatrist assessed side effects"}, {"PrimaryOutcomeMeasure"=>"Craving", "PrimaryOutcomeTimeFrame"=>"3x/week during 18 weeks of trial", "PrimaryOutcomeDescription"=>"subjective cravings were recorded on the Cocaine craving scale"}, {"PrimaryOutcomeMeasure"=>"Drug use", "PrimaryOutcomeTimeFrame"=>"3x/week during 18 weeks of trial", "PrimaryOutcomeDescription"=>"urine drug testing and self reported use on the Substance Use Weekly Inventory"}, {"PrimaryOutcomeMeasure"=>"Retention", "PrimaryOutcomeTimeFrame"=>"18 weeks or length of study participation", "PrimaryOutcomeDescription"=>"duration of individuals in the study."}]}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Cocaine", "METHADONE PATIENTS", "RISPERIDONE"]}, "ConditionList"=>{"Condition"=>["Cocaine-Related Disorders", "Substance-Related Disorders"]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents.\n\nThe study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This", "DetailedDescription"=>"This was an 18-week prospective, randomized, placebo-controlled crossover design with placebo lead-in phase and terminal placebo phase. After two weeks of single-blind placebo, patients were randomly assigned to one of two schedules of medication:\n\n2 Week Baseline Weeks 1-6 Weeks 7-12 Weeks 13-18 Group 1 placebo risperidone placebo placebo Group 2 placebo placebo risperidone placebo\n\nThe first 6-week phase provided an initial double-blind medication-placebo comparison. In the second six-week phase (weeks 7-12), patients crossed over to the opposite treatment. During weeks 13-18, Group 1 patients remained on placebo while Group 2 patients were tapered from risperidone to placebo. For six weeks after the end of the trial, patients were offered routine clinical treatment with counseling and psychiatrist visits as needed. Medication dosage was titrated upwards on a fixed-flexible schedule to a maximum dose of 4 mg per day. Medication began at ½ mg risperidone for 3 days, then 1 mg for four days, 2 mg per day during week 2, 3 mg per day during week 3, and 4 mg per day during weeks 4-6. The titration schedule for risperidone in weeks 7-12 was the same as for weeks 1-6. In addition to treatment as usual, patients received a modified manual-guided relapse prevention counseling program in weekly meetings lasting approximately 20 minutes; these sessions provided cognitive and behavioral skills that were found to be helpful to patients in reducing cocaine use."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"60 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion:\n\ngood standing at methadone maintenance program\nDSM-IV criteria for cocaine dependence or abuse\nused cocaine at least 4 times in last month\nable to give informed consent\n\nExclusion criteria\n\ncurrently meets DSM-IV criteria for Major depression or dysthymia\nmeets DSM-IV criteria for attention deficit hyperactivity disorder, bipolar disorder, schizophrenia or any psychotic disorder\nhistory of seizures\nhistory of allergic reaction to risperidone\nchronic organic mental disorder\nsignificant current suicidal risk\npregnancy, lactation or failure to use adequate birth control (for females)\nunstable physical disorders that may make participation hazardous\ncoronary vascular disease\ncardiac conduction system disease as indicated by QRS duration >/= 0.11\ncurrent use of other prescribed psychotropic medications\nhistory of failure to respond to a previous adequate trial of risperidone\nhistory of neuroleptic malignant syndrome, tardive dyskinesia, or severe extrapyramidal reactions to neuroleptic medications\ncurrent DSM-IV criteria for another substance dependence other than nicotine."}, "IdentificationModule"=>{"NCTId"=>"NCT00000317", "BriefTitle"=>"Early Phase II Trials for Cocaine Medication Development - 1", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"New York State Psychiatric Institute"}, "OfficialTitle"=>"Early Phase II Trials for Cocaine Medication Development", "NCTIdAliasList"=>{"NCTIdAlias"=>["NCT00000272"]}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"#3124"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01DA009582", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01DA009582", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"PLacebo", "ArmGroupDescription"=>"Placebo plus relapse prevention counseling", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Placebo", "Behavioral: Relapse prevention counseling"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Risperidone", "ArmGroupDescription"=>"Risperidone (4mg/day) plus relapse prevention counseling", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Risperidone", "Behavioral: Relapse prevention counseling"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Risperidone", "InterventionType"=>"Drug", "InterventionDescription"=>"Risperidone (4mg/day)", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Risperidal"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Risperidone"]}}, {"InterventionName"=>"Placebo", "InterventionType"=>"Drug", "InterventionDescription"=>"Placebo", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["PLacebo"]}}, {"InterventionName"=>"Relapse prevention counseling", "InterventionType"=>"Behavioral", "InterventionDescription"=>"Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention.", "InterventionOtherNameList"=>{"InterventionOtherName"=>["RPT-CBT"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["PLacebo", "Risperidone"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"10032", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"NYS Psychiatric Institute"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Edward Nunes, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"NYS Psychiatric Institute"}]}}, "IPDSharingStatementModule"=>{"IPDSharing"=>"No"}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"New York State Psychiatric Institute", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute on Drug Abuse (NIDA)", "CollaboratorClass"=>"NIH"}, {"CollaboratorName"=>"Research Foundation for Mental Hygiene, Inc.", "CollaboratorClass"=>"OTHER"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
