The PEARL-C1 trial is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Caregivers of patients with advanced cancer often experience high levels of distress but there is currently little evidence-based guidance on how to...
The PEARL Pilot is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Individuals with advanced cancer often experience high levels of distress due to physical suffering, difficult treatment decisions, social isolation, a...
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: 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...
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 ...
The escalating global burden of mental health disorders, coupled with the stagnation of innovation in traditional monoaminergic pharmacotherapy (e.g., SSRIs), has precipitated a critical need for novel therapeutic paradigms. This article presents a comprehensive systematic review of the so-called "Psychedelic Renaissance," focusing on the clinical resurgence...
“Magic mushrooms” produce a naturally occurring psychedelic compound called psilocybin. Public opinion surrounding psilocybin mushrooms generally holds that they are primarily used for recreational purposes, which may have contributed to their widespread prohibition in the United States. However, prior studies have demonstrated the potential efficacy of psil...
Existential and spiritual suffering are frequently reported by individuals facing serious illnesses, particularly at the end of life, and are associated with diminished quality of life, increased psychological distress, and requests for hastened death. While Palliative Care (PC) aims to provide holistic support, existing therapeutic options often fail to ade...
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...
Psilocybin, also known as “magic mushrooms,” is naturally found in psychedelic compound from different types of mushrooms. The utility of psilocybin for spiritual and therapeutic purposes has already go through several centuries. Scientific research on these compounds gained traction in the mid-20th century, the increasing interest in the possible therapeuti...
Psilocybin-assisted psychotherapy represents a promising addition to palliative care interventions, potentially improving quality of life by addressing existential distress. Despite its safety and effectiveness, this therapy remains limited in Canada, underscoring the need for improved access to ease suffering from life-threatening illnesses. However, import...
The purpose of this review is to provide a comprehensive overview of the current findings and data on the therapeutic effects of psilocybin, a naturally occurring psychedelic alkaloid primarily found in Psilocybe mushrooms. This review covers psilocybin's efficacy and safety profile, therapeutic effects, proposed indications and contraindications, drug-drug ...
This Comment explores the legal, ethical, and regulatory challenges surrounding the use of psilocybin-assisted psychotherapy for terminally ill patients under the federal Right to Try (RTT) Act. While psychedelics like psilocybin are demonstrating extraordinary therapeutic potential, particularly in easing end-of-life psychological distress, patients remain ...
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...
BackgroundThe interest in psychedelics as a therapeutic intervention for existential distress of people with terminal illness grounds on their mechanism of action and effect on the spiritual/existential aspects accompanying end-of-life experiences.AimsThis systematic review and network meta-analysis aimed at examining the efficacy and safety of psychedelic c...
Abstract Interest in psychedelic research in the West is surging, however, clinical trials have almost exclusively studied synthetic compounds such as MDMA, ketamine, DMT, LSD, ibogaine, and psilocybin. To date, few clinical trials have utilized whole mushroom/plant material like Psilocybe mushrooms, Iboga, or Ayahuasca. Individuals participating in the Root...
OBJECTIVES: Promising studies show that psilocybin-assisted therapy relieves existential distress in patients with serious illnesses, a difficult condition to treat with current treatment options. There is growing interest in this therapy in palliative care. Canada recently amended its laws to allow physicians to request psilocybin for end-of-life distress. ...
Introduction:Psilocybin-assisted therapy (PAT) has gained traction in palliative care as a treatment for existential distress in the last decade. Patients with brain cancer have been excluded from studies, yet they stand to benefit as much as other patients with cancer-related psychological distress. Case description:In this report, we discuss the case of a ...
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...
Background: Internationally, there is a growing interest in the potential benefits of psilocybin-assisted therapy to treat existential distress at the end of life. However, the social acceptability of this therapy is not yet well known. Aim: This study assesses the social acceptability of the medical use of psilocybin to treat existential distress at the end...
