[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Charles S. Grob, M.D.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27],"Demoralization",[29,30,31,32],"Palliative Care","Serious Medical Illness","Life-threatening Condition","Advanced and Progressive Illness","RECRUITING","2025-11-21",{"date":36,"type":37},"2025-11-25","ACTUAL",{"date":39,"type":37},"2025-01-19",{"date":41,"type":21},"2027-12-31",{"name":43,"class":44},"Charles S. Grob, M.D.","OTHER",5,""]