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...
Informed by a community engagement process, we have developed a pragmatic, open-label, hybrid feasibility-implementation study of Group Psilocybin-Assisted Therapy (GPAT) for post-traumatic stress disorder (PTSD). As psychedelic-assisted therapies begin to enter the broader mental health arena, engaging communities in the design of research and care models i...
Background: Understanding the benefits of psychedelic-assisted therapy (PAT) will require scientific attention to the causal interaction between the therapeutic context and process. Measuring what actually happens during PAT in large-scale studies will be an essential component of this work. Objective: We aim to develop and preliminarily evaluate the feasibi...
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 ...
Abstract Rationale The elderly population is rapidly growing. Overwhelming epidemiologic data has demonstrated worse health outcomes with increasing age for a multitude of lung diseases (COVID being one of numerous examples). There is an increasingly urgent need for a more complete understanding of the molecular pathways and biological processes underlying a...
Chronic pain states remain challenging to control with current drug therapies. Here, we demonstrate that a single dose of psilocybin produces a sustained anti-nociceptive effect in chronic neuropathic pain models in male and female mice, mediated primarily by 5-HT2A receptors. Critically, psilocybin significantly potentiates the analgesic efficacy of gabapen...
The goal of this pilot clinical trial is to learn whether it is feasible to individually tailor psilocybin-assisted psychotherapy (PAP) for people with treatment-resistant depression (TRD) based on their personal preferences. The study also aims to explore whether two different psychotherapy styles, music-centered and mindfulness-centered, influence how peop...
This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gai...
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...
The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people ...
BACKGROUND: Treatment-resistant depression (TRD) imposes a substantial public health and economic burden. Although psilocybin-assisted therapy (PAT) has shown clinical promise, its economic value remains uncertain. This study evaluated the cost-effectiveness of PAT compared with the standard of care for TRD. METHODS: A Markov model adopting a US healthcare p...
This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care buprenorphine treatment for Opioid use disorder (OUD). Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with bupr...
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 ...
Psilocybin is the primary psychoactive compound in "magic mushrooms"; it has been used by humans for millennia, it is in promising clinical trials with humans and used in legalized psilocybin-assisted therapy, and researchers use and are further developing human-based methods with cutting-edge technologies.However, researchers are still allowed to conduct un...
The goal of this clinical trial is to evaluate whether a single dose of psilocybin is feasible and safe for adults with opioid use disorder (OUD) who are recovering from trauma surgery. The main questions it aims to answer are: 1. Is a single psilocybin dose feasible to administer during postoperative hospitalization? 2. Is psilocybin safe in this patient po...
There has been a renewed interest in the use of various psychedelic agents as potential therapies for multiple psychiatric conditions, including post-traumatic stress disorder (PTSD), major depressive disorder (MDD), generalized anxiety disorder (GAD), to name a few. This follows the recent accumulation of evidence for ketamine pharmacotherapy and a rapid pr...
This is a double-blind, adaptive, 2-stage, multi-site, phase 2 randomized controlled clinical trial designed to evaluate effects of moderate and high dose psilocybin, relative to low-dose psilocybin control, in OUD patients who continue to use illicit opioids in spite of adherence to standard-of-care treatment with methadone. Up to 480 participations will be...
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...
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals. Individuals with OCD often have diminished quality of life, and functional impairment. The disorder cause high personal, societal and economic costs. Current availab...
