[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470226":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":133,"collaborators":136,"id":139,"slug":40,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":40,"enrollmentInfo":148,"targetDuration":40,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":49,"whyStopped":40,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"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. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride.",[15],[31],"Ketalar",[33],{"name":34,"affiliation":5,"role":35},"Charles S. Grob, M.D.","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","(626) 522-8615",null,"pt2pc@lundquist.org",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Brian T Anderson, M.D.","(510) 985-3522","pt2pc@ucsf.edu",[47,69,87,100,114],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Marin Cancer Care","RECRUITING","Greenbrae","California","94904","United States",{"type":55,"coordinates":56},"Point",[57,58],-122.5247,37.94854,{"lat":58,"lon":57},[61,65],{"name":62,"role":38,"phone":63,"phoneExt":40,"email":64},"Barbara M. Galligan, M.D.","415-925-5000","pt2pc@marincancercare.com",{"name":66,"role":38,"phone":67,"phoneExt":40,"email":68},"Joshua S Biddle, M.D.","(415) 465-0481","Joshua.Biddle@mymarinhealth.org",{"facility":70,"status":49,"city":71,"state":51,"zip":72,"country":53,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University of California, Los Angeles","Los Angeles","90095",{"type":55,"coordinates":74},[75,76],-118.24368,34.05223,{"lat":76,"lon":75},[79,83],{"name":80,"role":38,"phone":81,"phoneExt":40,"email":82},"Ziva M. Cooper, Ph.D.","310-983-3417","ZCooper@mednet.ucla.edu",{"name":84,"role":38,"phone":85,"phoneExt":40,"email":86},"Katrina F DeBonis, M.D.","(310) 206-1596","KDeBonis@mednet.ucla.edu",{"facility":88,"status":49,"city":89,"state":51,"zip":90,"country":53,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"University of San Francisco","San Francisco","94518",{"type":55,"coordinates":92},[93,94],-122.41942,37.77493,{"lat":94,"lon":93},[97],{"name":98,"role":38,"phone":99,"phoneExt":40,"email":45},"Brian T. Anderson, M.D.","510-985-3522",{"facility":5,"status":49,"city":101,"state":51,"zip":102,"country":53,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Torrance","90502",{"type":55,"coordinates":104},[105,106],-118.34063,33.83585,{"lat":106,"lon":105},[109,112],{"name":110,"role":38,"phone":111,"phoneExt":40,"email":41},"Charles S Grob, M.D.","626-522-8615",{"name":113,"role":38,"phone":39,"phoneExt":40,"email":41},"Michael Makhinson, M.D.",{"facility":115,"status":49,"city":116,"state":117,"zip":118,"country":53,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Sunstone Therapies","Rockville","Maryland","20850",{"type":55,"coordinates":120},[121,122],-77.15276,39.084,{"lat":122,"lon":121},[125,129],{"name":126,"role":38,"phone":127,"phoneExt":40,"email":128},"Manish Agrawal, M.D.","301-337-7570","manish.agrawal@sunstonetherapies.com",{"name":130,"role":38,"phone":131,"phoneExt":40,"email":132},"Kimberly Roddy, MBA","(301) 750-3401","kim.roddy@sunstonetherapies.com",{"type":134,"investigatorFullName":34,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Professor of Psychiatry and Behavioral Sciences",[137],{"name":138,"class":6},"University of California, San Francisco","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":149,"type":150},100,"ESTIMATED","INTERVENTIONAL",[153],"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).",[156],"Demoralization",[158,159,160,161],"Palliative Care","Serious Medical Illness","Life-threatening Condition","Advanced and Progressive Illness","2025-11-21",{"date":164,"type":165},"2025-11-25","ACTUAL",{"date":167,"type":165},"2025-01-19",{"date":169,"type":150},"2027-12-31",{"name":34,"class":6},5]