[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470226":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":134,"collaborators":137,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":142,"sex":148,"minAge":149,"maxAge":40,"enrollmentInfo":150,"targetDuration":40,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":49,"whyStopped":40,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Psilocybin","EXPERIMENTAL","A single moderate-to-high dose of oral psilocybin, plus 4-5 sessions of a brief, existential psychotherapy.",[13],"Drug: Psilocybin",{"label":15,"type":16,"description":17,"interventionNames":18},"Ketamine","ACTIVE_COMPARATOR","A single low-to-moderate dose of oral liquid ketamine, plus 4-5 sessions of a brief, existential psychotherapy.",[19],"Drug: Ketamine",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Psilocybin, \\[3-\\[2-(dimethylamino)ethyl\\]-1H-indol-4-yl\\] dihydrogen phosphate.",[9],[26],"Hallucinogen",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"ketamine hydrochloride injection, for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic and has a molecular formula of C13H16ClNO•HCl and a molecular weight of 274.19. 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Galligan, M.D.","415-925-5000","pt2pc@marincancercare.com",{"name":67,"role":38,"phone":68,"phoneExt":40,"email":69},"Joshua S Biddle, M.D.","(415) 465-0481","Joshua.Biddle@mymarinhealth.org",{"facility":71,"status":49,"city":72,"state":51,"zip":73,"country":53,"countryCode":54,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"University of California, Los Angeles","Los Angeles","90095",{"type":56,"coordinates":75},[76,77],-118.24368,34.05223,{"lat":77,"lon":76},[80,84],{"name":81,"role":38,"phone":82,"phoneExt":40,"email":83},"Ziva M. Cooper, Ph.D.","310-983-3417","ZCooper@mednet.ucla.edu",{"name":85,"role":38,"phone":86,"phoneExt":40,"email":87},"Katrina F DeBonis, M.D.","(310) 206-1596","KDeBonis@mednet.ucla.edu",{"facility":89,"status":49,"city":90,"state":51,"zip":91,"country":53,"countryCode":54,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"University of San Francisco","San Francisco","94518",{"type":56,"coordinates":93},[94,95],-122.41942,37.77493,{"lat":95,"lon":94},[98],{"name":99,"role":38,"phone":100,"phoneExt":40,"email":45},"Brian T. Anderson, M.D.","510-985-3522",{"facility":5,"status":49,"city":102,"state":51,"zip":103,"country":53,"countryCode":54,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Torrance","90502",{"type":56,"coordinates":105},[106,107],-118.34063,33.83585,{"lat":107,"lon":106},[110,113],{"name":111,"role":38,"phone":112,"phoneExt":40,"email":41},"Charles S Grob, M.D.","626-522-8615",{"name":114,"role":38,"phone":39,"phoneExt":40,"email":41},"Michael Makhinson, M.D.",{"facility":116,"status":49,"city":117,"state":118,"zip":119,"country":53,"countryCode":54,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Sunstone Therapies","Rockville","Maryland","20850",{"type":56,"coordinates":121},[122,123],-77.15276,39.084,{"lat":123,"lon":122},[126,130],{"name":127,"role":38,"phone":128,"phoneExt":40,"email":129},"Manish Agrawal, M.D.","301-337-7570","manish.agrawal@sunstonetherapies.com",{"name":131,"role":38,"phone":132,"phoneExt":40,"email":133},"Kimberly Roddy, MBA","(301) 750-3401","kim.roddy@sunstonetherapies.com",{"type":135,"investigatorFullName":34,"investigatorTitle":136,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Professor of Psychiatry and Behavioral Sciences",[138],{"name":139,"class":6},"University of California, San Francisco","100470226","phase-2-pragmatic-trial-of-psilocybin-therapy-in-palliative-care-100470226",false,"NCT05403086","Pragmatic Trial of Psilocybin Therapy in Palliative Care","Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC): A Multicenter Triple-blind Phase 2 Randomized Controlled Trial of Psilocybin Therapy for Demoralized Adults Near the End of Life","PT2PC","Inclusion Criteria:\n\nGeneral\n\n* Provision of signed and dated informed consent form and the capacity to consent to research.\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Is currently a patient in a study-engaged clinical site\n* Has a life-threatening illness and a life expectancy of ≤2 years\n* Has moderate-to-severe demoralization\n* Ability to take oral medication (capsules and liquid)\n\nExclusion Criteria:\n\nGeneral\n\n* Known allergic or severe reactions to the non-psychoactive components of psilocybin capsules or liquid ketamine\n* Treatment with another investigational drug or intervention within 1 month of signing Informed Consent Form (ICF)\n* If deemed by clinical judgment of the study investigators to be unsafe for undergoing the intervention\n\nNeurological\n\n* Cognitive impairment sufficient to impede the ability to complete study tasks\n* History of intracranial hemorrhage\n* Recent embolic stroke\n* Recent seizure\n* Current intracranial mass\n* Advanced stage of a neurologic disease that elevates risk for psychosis\n\nCardiovascular\n\n* Uncontrolled hypertension\n* Clinically significant cardiac disease\n\nRespiratory\n\n* Severe pulmonary disease\n* Supplemental oxygen requirement\n\nGastrointestinal\n\n* Current intractable nausea\u002Fvomiting\u002Fdiarrhea\n* Recent, clinically significant GI bleed\n* Markedly abnormal liver function tests\n\nEndocrine, Renal, and Reproductive\n\n* Pregnancy or lactation\n* Severe renal insufficiency\n* Unstable insulin-dependent diabetes mellitus\n\nProhibited Medications\n\n* Antipsychotics (with exceptions)\n* Antidepressants (with exceptions)\n* Dopamine agonists\n* Drugs known to have adverse interactions with psilocybin or ketamine","ALL","18 Years",{"count":151,"type":152},100,"ESTIMATED","INTERVENTIONAL",[155],"PHASE2","This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).",[158],"Demoralization",[160,161,162,163],"Palliative Care","Serious Medical Illness","Life-threatening Condition","Advanced and Progressive Illness","2025-11-21",{"date":166,"type":167},"2025-11-25","ACTUAL",{"date":169,"type":167},"2025-01-19",{"date":171,"type":152},"2027-12-31",{"name":34,"class":6},5]