This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings o...
The goal of this clinical trial is to evaluate whether psilocybin therapy can effectively treat depression and psychological distress in adult patients with COPD, ALS, MS, or APD who have at least 6 months life expectancy. The main questions it aims to answer are: * Can psilocybin therapy safely reduce depressive symptoms compared to low-dose control? * Will...
Background: Terminally ill patients often experience significant psychosocial distress having depressed mood, death anxiety, pain, and an overall poor quality of life. Recent evidence from pilot studies suggests that serotonergic hallucinogens including lysergic acid diethylamide (LSD) and psilocybin produce significant and sustained reductions of depressive...
Demoralization syndrome is frequently present in palliative care and oncology patients. In particular, up to a third of patients diagnosed with cancer will experience demoralization due to their illness. The relevance of demoralization syndrome in oncology is tied to this syndrome's association with other mental health ailments such as depression, anxiety, s...
The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that limit functionality) in the treatment of mo...
Meaning is a primary existential concern in those with advanced illnesses and functions as an important coping mechanism. Loss of meaning contributes to existential distress, and, in particular, may manifest as demoralization, a syndrome of poor coping that is associated with negative outcomes. Psychedelics are unique psychoactive compounds that, among other...
The overall objective of this study is to develop and pilot test a novel regimen of psilocybin-assisted psychotherapy for demoralization in patients receiving hospice care. -The name of the study drug involved in this study is Psilocybin The purpose of this research is to understand how psilocybin-assisted therapy may be adapted in the context of hospice car...
Demoralization syndrome (DS) - a distinct clinical entity characterized by helplessness, hopelessness, and a persistent loss of meaning - affects approximately one in five Canadians with advanced cancer and is associated with increased desire for hastened death, negative clinical outcomes, and higher economic burden, yet recognition and treatment of DS remai...
BACKGROUND: Psychological distress is a common problem near the end of life, for which we lack effective, timely and scalable treatments. No previous study has assessed whether microdose psilocybin can improve symptoms in this population. AIM: To determine whether microdose psilocybin is safe, feasible and potentially efficacious in a palliative setting. DES...
The CAnadian Network for Psychedelic-Assisted Cancer Therapy (CAN-PACT) was launched in 2025 to address urgent gaps in supportive care for Canadians with cancer experiencing demoralization syndrome (loss of meaning, dysphoria, disheartenment, helplessness, a sense of failure) and related psychosocial distress. CAN-PACT has six major objectives: (1) to develo...
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with...
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). After providing written informed consent, participants deemed eligible for this trial will be randomized to a brief...
Supplement 1. Additional tables presenting primary and secondary outcomes, sensitivity analyses, and exploratory findings. Table A1. ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table A2. Adjusted ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table B1. Intent-To-Treat (ITT) Analysis for Demoralization Scale (DSII) and PTSD Checklist for DSM-5 (PCL-5). Table B2....
BACKGROUND: Depression and burnout, which are common among healthcare workers, were exacerbated by the COVID-19 pandemic. Mindfulness-Based Stress Reduction (MBSR) and psilocybin have been reported to reduce depressive symptoms, but the efficacy of the combination requires comparison to an active treatment control. We sought to evaluate the safety and prelim...
Novel phenalkylamines and tryptamines such as psilocybin demonstrate promising nontraditional pharmacological profiles for treating psychiatric syndromes. Structural modifications yield functional selectivity at 5-HT receptors, mitigating hallucinogenic risk while preserving therapeutic efficacy. This study integrates receptor and behavioral data to support ...
IMPORTANCE: Psilocybin-assisted psychotherapy may offer a novel approach to treating depression, anxiety, and existential distress in individuals with life threatening illnesses, where current treatments show limited efficacy. OBJECTIVE: To evaluate the efficacy and safety of psilocybin-assisted psychotherapy versus active placebo and psychotherapy in adults...
This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with demoralization and chronic pain. Cancer patients often experience demoralization, which is characterized by feelings of hopelessness, loss of meaning, and existential distress. Psilocybin psychotherapy, together w...
This scoping review addresses the need to comprehensively explore the potential of psychedelic-assisted psychotherapy (PAP) to facilitate recovery from moral injury. Moral injury (MI), characterized by profound psychological distress arising from morally challenging experiences, has garnered increased attention as a complex mental health concern with signifi...
= 7) in an open-label trial investigating PAT for cancer-related demoralization and chronic pain. Patients and caregivers were interviewed after their last treatment session in the trial; facilitators were interviewed at the end of the entire trial. Rapid qualitative analysis identified specific domains for improvement in the treatment protocol based on the ...
