BACKGROUND: Patients with cancer often struggle with depression, which can negatively impact quality of life as well as be challenging to manage. METHODS: A phase 2 trial was conducted that demonstrated safety, feasibility, and efficacy of a single dose of psilocybin combined with psychological support in a community cancer setting in 30 patients with cancer...
The goal of this clinical trial is to test the feasibility of combining meditation with psilocybin microdosing in healthy adults. The main questions it aims to answer are: 1. Recruitment and retention feasibility 2. Acceptability, Safety and Tolerability 3. Exploratory Measures: 3.1: Explore potential changes in sleep quality and duration, heart rate variabi...
Objective Despite many decades of experimental studies and clinical trials involving a variety of psychedelic agents, we still lack a comprehensive understanding of the effects of these substances on psychological experiences. As such, we designed and conducted a study to comprehensively characterise the effects of both psilocybin and 3,4-Methylenedioxymetha...
BACKGROUND: Psychedelic treatment is a rapidly emerging therapeutic approach for a host of chronic, difficult to treat psychiatric disorders, including anorexia nervosa (AN). Trauma and its sequelae, such as dissociation, often contribute to comorbidity and treatment refractoriness. AIMS: In this report, we describe the therapeutic emergence of previously di...
Ketamine and its enantiomers, esketamine and arketamine, have emerged as promising treatments for treatment-resistant depression (TRD). This cross-sectional study evaluates the regulatory alignment of 40 clinical trials listed on ClinicalTrials.gov, focusing on the methodological challenges. The study highlights methodological inconsistencies, particularly a...
Background: Although historical writings, anthropological accounts, and experimental studies document associations between psilocybin use and religion, no prospective experimental study has investigated how the effects of psilocybin are experienced and interpreted by religious clergy. This exploratory study evaluated the overall safety and the acute and endu...
Abstract Music is integral to Psilocybin-assisted psychotherapy (PAP), believed to enhance therapeutic outcomes by structuring experiences and facilitating emotional expression. However, the effects of conducting PAP without music are underexplored. This study examines the experiences of two breast cancer patients undergoing psilocybin therapy under Canada's...
Objective To evaluate psilocybin's efficacy in reducing depressive and anxiety symptoms in cancer patients based on randomized controlled trials (RCTs). Methods This systematic review and network meta-analysis (NMA) followed PRISMA and Cochrane Handbook guidelines. PubMed, Embase and Cochrane Library data up to July 2024 were analyzed. Two RCTs met the inclu...
Psilocybin, a serotonergic psychedelic, may have therapeutic benefits for Substance Use Disorders (SUDs), but its overall efficacy and safety remain uncertain. This systematic review assessed the safety and efficacy of psilocybin for SUDs through a systematic database search conducted via OVID on May 22, 2024, and summarized 26 ongoing clinical trials regist...
INTRODUCTION: Prolonged grief disorder (PGD) represents a substantial public health issue, especially in oncology settings where it affects up to 30% of bereaved carers. Current best-practice treatments are lengthy, and up to 50% of participants have persistent PGD. Building on encouraging recent research with psychedelic-assisted therapies, the Psilocybin-A...
The largest randomized study of psilocybin to date demonstrated the efficacy of COMP360 25 mg (Compass Pathways' investigational proprietary pharmaceutical-grade synthesized psilocybin formulation) in participants with treatment-resistant depression (COMP001), compared with 10 mg and 1 mg doses. Here, we report findings from COMP004, a 52-week observational ...
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...
BackgroundPsychedelic assisted psychotherapy (PAP) can improve treatment-resistant depression. Its usefulness in Parkinson's disease (PD) is unknown. PD patients may have problems adjusting to their chronic progressive neurological disease. A change from emotional avoidance to acceptance has been reported following psilocybin administration in patients with ...
BACKGROUND: Obsessive-compulsive disorder (OCD) is a complex condition marked by persistent distressing thoughts and repetitive behaviours. Despite its prevalence, the mechanisms behind OCD remain elusive, and current treatments are limited. This protocol outlines an investigative study for individuals with OCD, exploring the potential of psilocybin to impro...
• A60-year-old man with recurrent depression and history of delusions died after psilocybin-assisted therapy. • Psilocybin-triggered delusions and emotional dysregulation may have contributed. • Weak therapeutic alliance hindered assessment of patient's internal state. • Delusional symptoms may contraindicate psychedelic interventions. • This case emphasizes...
Abstract The discussion surrounding the necessity of acquiring personal experience of non-ordinary states of consciousness in the course of psilocybin-assisted therapy training is crucial, as it can affect treatment safety, effectiveness and accessibility. As such, the ethical and practical issues associated with such a training standard require timely consi...
OBJECTIVE: Evidence suggests that psilocybin-assisted therapy (PAT) leads to durable shifts in personality structure. However, such changes have yet to be characterized in disorders of addiction. In this secondary analysis from a randomized controlled trial, the authors examined the effect of PAT on personality dimensions in patients with alcohol use disorde...
ImportanceA clear and comprehensive understanding of risks associated with psychedelic-assisted therapy is necessary as investigators extend its application to new populations and indications.ObjectiveTo assess adverse events (AEs) associated with classic psychedelics, particularly serious AEs (SAEs) and nonserious AEs (NSAEs) requiring medical or psychiatri...
BackgroundTreatment with so-called psychedelic drugs, including psilocybin, lysergic acid diethylamide (LSD), and others, is among the most promising recent developments in psychiatry. This review focuses on psilocybin, a substance found in all mushrooms of the genus Psilocybe, because the largest amount of available evidence relates to this drug.MethodsThis...
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...
