Informed consent in psychedelic-assisted services is ethically complex, difficult to implement, and remains largely unstudied and unstandardized. The current study sought expert recommendations on informed consent challenges, best practices and recommendations for supervised psilocybin experiences across various settings. Participants with psilocybin content...
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...
Mystical experiences are characterized by a profound sense of interconnectedness and transcendence of ordinary reality. These experiences can facilitate feelings of connectedness with oneself and others and have been documented as leading to significant positive changes in thoughts, emotions, and behavior. The purpose of the present study was to evaluate the...
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...
About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress. Treatment options such as medication and therapy are available; however, they do not always work and can be time-consuming and expensive. We need treatments that work well, quickly, and ...
Background: Emotional distress is often comorbid with serious illness, especially in individuals facing social stigmas, such as patients with HIV. Death acceptance may serve as a protective factor against such distress. Standard psychopharmacologic interventions have shown insufficient results in alleviating distress associated with serious illness. Prelimin...
OBJECTIVE: Anxiety is common in patients receiving end-of-life care and significantly impacts their quality of life. However, pharmacological management remains challenging due to complex clinical presentations and potential side effects, emphasizing the need for systematically reviewing existing treatments. Here we aim to systematically evaluate the efficac...
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 narrative review synthesized the use of psilocybin-assisted therapy as a promising treatment for alleviating death anxiety in terminally ill patients. The insights presented are derived from findings reported in previous studies. Therefore, this review aimed to assess the efficacy, pharmacology, and mechanisms by which psilocybin alters brain function b...
There are profound methodological challenges facing microdosing research. One way we can address some of these methodological issues is by understanding how psilocybin microdosing fits in the broader existential context of people’s lives. We recruited participants who underwent psilocybin microdosing on their own and consented to being monitored for harm mit...
The purpose for this study is to observe the real world experience of participants who are receiving psilocybin in the context of (alcoholism) Alcohol Use Disorder without intervening in the model of care. The study team will engage directly with the participants to examine the outcomes in participants who have been deemed eligible and appropriate to receive...
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....
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...
PurposeTo evaluate the current level of evidence for the use of psychedelics for the management of cancer pain and associated psychological distress.ContentPain is a common symptom of cancer and treatment. However, there are high rates of undertreatment of cancer pain due to the complex underlying biology of the condition, and potentially due to a decrease i...
Abstract Background and Aims Networks of so-called underground, or illegal, psilocybin mushroom practitioners are popularly known to exist, though few systematic investigations of their practices have been conducted. We sought to uncover the experiences of a hidden community of psilocybin practitioners in order to inform scientific and policy dialogues about...
Patients with a life-threatening disease (LTD) sometimes suffer from end-of-life distress (EOLD) which refers to the physical, psychological, emotional, and spiritual suffering related to chronic illness and the possibility of death. Palliative care interventions seek to improve the quality of life of patients with EOLD and their significant others. Currentl...
OBJECTIVES: Psychospiritual distress affects many patients with cancer, contributing to diminished quality of life, decreased survival and a desire for hastened death. The current standard of care, which primarily consists of antidepressants and psychotherapy, has demonstrated only modest benefits. Psilocybin-assisted therapy (PAT) has shown evidence of rapi...
Existential distress is commonly experienced by patients diagnosed with a life-threatening illness. This condition has been shown to adversely impact quality of life and is correlated with increased suicidal ideation and requests for hastened death. While palliative care teams are experienced in treating depression and anxiety, existential distress is a dist...
The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered vi...
