{ "FullStudy":{ "Rank":218306, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510015", "OrgStudyIdInfo":{ "OrgStudyId":"0503-11-TLV" }, "Organization":{ "OrgFullName":"Tel-Aviv Sourasky Medical Center", "OrgClass":"OTHER_GOV" }, "BriefTitle":"Evaluation of the Effects of Treatment of Psycho-stimulant and Cannabis-dependent Users in Israel", "OfficialTitle":"Evaluation of the Effects of Psychological and Pharmacological Treatment of Psycho-stimulant and Cannabis-dependent Users in Kfar Izun in Israel" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Not yet recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2013", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"November 2013", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"December 27, 2011", "StudyFirstSubmitQCDate":"January 10, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 13, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 10, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 13, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Michal Roll PhD,MBA", "ResponsiblePartyInvestigatorTitle":"Head of Research and Development", "ResponsiblePartyInvestigatorAffiliation":"Tel-Aviv Sourasky Medical Center" }, "LeadSponsor":{ "LeadSponsorName":"Tel-Aviv Sourasky Medical Center", "LeadSponsorClass":"OTHER_GOV" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This study evaluates the effects of psychological and pharmacological treatment of regular users of cannabis and psychostimulants in a treatment center (Kfar Izun) in Israel. The participants will undergo psychological evaluation before and during treatment and follow up at 4 months. Ten participants will undergo brain imaging of the dopamine receptor D2 in order to evaluate the effects of treatment on dopamine turnover in the brain. A control group of psychiatric in-patients undergoing treatment for psychiatric illness with be recruited from Geha Hospital in Israel. It is predicted that successful treatment of regular users of cannabis will be resulted in improvement in anxiety, depression and psychotic symptoms as well as in upregulation of dopamine turnover in participants that will undergo brain imaging.", "DetailedDescription":"There is a significant number of cannabis and psychostimulant users that experience psychotic episodes and require psychiatric treatment. This study evaluates the effects of psychological and pharmacological treatment of regular users of cannabis and psychostimulants in a treatment center (Kfar Izun) in Israel. The participants will undergo psychological evaluation before and during treatment and follow up at 4 months. Ten participants will undergo brain imaging of the dopamine receptor D2 using [I123] IBZM in Single Photon Emitted Tomography (SPECT) before and after treatment in order to evaluate the effects of treatment on dopamine turnover in the brain. A control group of psychiatric in-patients undergoing treatment for psychiatric illness with be recruited from Geha Hospital in Israel." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Cannabis Dependence", "Psychostimulant Dependence" ] }, "KeywordList":{ "Keyword":[ "cannabis", "psychostimulants", "psychosis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"100", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Anti-psychotic medication", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Participants are treated with psychological treatment both group and individually as well as medications according to their mental condition.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Risperidone" ] } },{ "ArmGroupLabel":"Counseling", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Participants will receive individual and group therapy", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Risperidone" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Risperidone", "InterventionDescription":"variable dose", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Anti-psychotic medication", "Counseling" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Individual and group therapy" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Questionnaire ratings of anxiety, depression and psychotic symptoms", "PrimaryOutcomeDescription":"Questionnaire measures of anxiety (Spielberger) Depression (BDI) and psychotic symptoms (PNAAS) will be used at baseline, during treatment and follow up at 4 months", "PrimaryOutcomeTimeFrame":"4 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Dopamaine receptor D2 occupancy", "SecondaryOutcomeDescription":"Measures of dopamine receptor D2 occupancy using [I123] IBZM in Single Photon Emitted Tomography (IBZM) will be taken before and after treatment at 4 months.", "SecondaryOutcomeTimeFrame":"At baseline and after 4 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\ncannabis dependence with or without history of psychosis.\n\nExclusion Criteria:\n\npregnant women\nunder 18\nneurological damage\nHIV positive\ndependence on other drugs such as heroin\ncocaine or alcohol", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"21 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Aviv M Weinstein, Ph.D", "CentralContactRole":"Contact", "CentralContactPhone":"+97236973536", "CentralContactEMail":"avivweinstein@yahoo.com" },{ "CentralContactName":"Hedva Shaham, M.D", "CentralContactRole":"Contact", "CentralContactPhone":"+97236973536", "CentralContactEMail":"hedval@gmail.com" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Michal Roll, Ph.D", "OverallOfficialAffiliation":"Sourasky Medical Center", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Sourasky Medical center", "LocationCity":"Tel Aviv", "LocationZip":"64239", "LocationCountry":"Israel", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Aviv Weinstein, Ph.D", "LocationContactRole":"Principal Investigator" },{ "LocationContactName":"Einat Even-Sapir, MD Ph.D", "LocationContactRole":"Principal Investigator" },{ "LocationContactName":"Hedva Lerman-Shaham, MD", "LocationContactRole":"Sub-Investigator" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "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":"M19583", "InterventionBrowseLeafName":"Risperidone", "InterventionBrowseLeafAsFound":"Risperidone", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M14095", "InterventionBrowseLeafName":"Serotonin", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15487", "InterventionBrowseLeafName":"Antipsychotic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M13057", "InterventionBrowseLeafName":"Psychotropic Drugs", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M6056", "InterventionBrowseLeafName":"Dopamine", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19180", "InterventionBrowseLeafName":"Dopamine Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M16545", "InterventionBrowseLeafName":"Dopamine Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"PsychDr", "InterventionBrowseBranchName":"Psychotropic Drugs" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"CaAg", "InterventionBrowseBranchName":"Cardiotonic Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000002189", "ConditionMeshTerm":"Marijuana Abuse" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000019966", "ConditionAncestorTerm":"Substance-Related Disorders" },{ "ConditionAncestorId":"D000064419", "ConditionAncestorTerm":"Chemically-Induced Disorders" },{ "ConditionAncestorId":"D000001523", "ConditionAncestorTerm":"Mental Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4031", "ConditionBrowseLeafName":"Marijuana Abuse", "ConditionBrowseLeafAsFound":"Cannabis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20421", "ConditionBrowseLeafName":"Substance-Related Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M28889", "ConditionBrowseLeafName":"Chemically-Induced Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC25", "ConditionBrowseBranchName":"Substance Related Disorders" } ] } } } } } }