To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer. Primary Objective To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for participants with depression and/or anxiety who are being actively...
This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety. Primary Objective: To examine the feasibility, safety, effect size estimates of psilocybin-assisted psychotherapy for cancer survivor patients with depression and/or anxiety. Feasibility...
To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo. Primary Objective 1\. To assess the efficacy of psilocybin in...
This phase II trial studies whether psilocybin with psychotherapy is safe and if it works for improving chronic pain in cancer patients who require opioids to manage their pain. Psilocybin is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to b...
Background/Objectives: Psilocybin-assisted therapy (PAT) is a promising intervention to alleviate existential distress among patients with advanced cancer receiving palliative care. However, evidence on how to integrate PAT into routine oncology and palliative care services remains scarce. This study aimed to examine real-world PAT implementation, identify f...
Psychological distress, such as anxiety and depression, is common among people with cancer and is often worsened by existential worries about mortality, loss of meaning, and decreased quality of life. Standard treatments, including medication and psychotherapy, often offer limited or short-term relief, highlighting the need for new, integrative psychosocial ...
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...
Introduction: Psilocybin therapy has demonstrated efficacy for cancer-related anxiety and depression, but resource-intensive individual treatment models raise important questions for psychedelic public health about equitable access and scalability. In our prior Phase 1/2 study of group retreat psilocybin therapy for patients with metastatic cancer, we observ...
BACKGROUND: Major depression is a prevalent condition among patients with life-threatening illnesses, such as cancer, and recent findings suggest that psilocybin may hold promising treatment potential. Contemporary trials of psilocybin generally employ a model that includes psychotherapeutic support consisting of preparation and integration sessions surround...
Depression and psychological distress are highly prevalent among patients with cancer and are associated with impaired quality of life, reduced treatment adherence, and poorer clinical outcomes. Standard pharmacological and psychosocial interventions often demonstrate limited efficacy or delayed onset of action in oncological and palliative settings. Psilocy...
INTRODUCTION: This article presents a narrative review of psilocybin-assisted psychotherapy as a promising intervention for addressing anxiety, depression and psycho-existential distress in patients with advanced cancer. This group of disorders, often resistant to conventional treatments, significantly impacts patients' quality of life and autonomy, as well ...
People with cancer often experience anxiety and depression following a diagnosis and can face barriers to accessing treatment for their mental health. An increasing number of patients are considering alternative approaches to managing their mental health symptoms, such as the psychedelic, psilocybin. A growing number of clinical trials show significant and e...
Psilocybin-assisted interventions have shown rapid reductions in depressive symptoms in controlled clinical settings, raising questions about biological mechanisms supporting durability beyond the acute drug effect. [5,7] Mechanistic accounts increasingly focus on neuroplasticity as a candidate pathway linking transient serotonergic receptor activation to lo...
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...
Background: Psilocybin is a promising therapy for cancer-related distress, but existing individual treatment models are resource intensive. In this study, we designed and tested a group model of psilocybin therapy for people with metastatic cancer and cancer-related anxiety and depression. Method: Eligibility criteria included metastatic cancer, moderate-to-...
People with cancer often experience anxiety and depression following a diagnosis and can face barriers to accessing treatment for their mental health. An increasing number of patients are considering alternative approaches to managing their mental health symptoms, such as the psychedelic, psilocybin. A growing number of clinical trials show significant and e...
INTRODUCTION: Psilocybin may effectively treat psychological distress in cancer patients. A meta-analysis assessed its safety and effectiveness in this context. METHODS: A comprehensive search across six databases (Scopus, PsycINFO, PubMed, Cochrane, CINAHL Complete, and Web of Science) was conducted to identify studies on psilocybin's effects on mental heal...
OBJECTIVE: The goals of this study were to examine the therapeutic effects and safety of psilocybin given as a pulsed regimen for the prevention of migraine and to consider the blinding integrity of an active control agent. BACKGROUND: The administration of a single low dose of psilocybin was observed to have lasting therapeutic effects in one small pilot tr...
