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...
Abstract Rationale: Major depressive disorder (MDD) shows marked sex differences in prevalence, symptomatology, and treatment response. However, women remain underrepresented in many clinical trials, and sex-specific treatment outcomes are rarely examined. Objectives This study reanalyzed data from a randomized controlled trial comparing psilocybin and escit...
Treatment-resistant depression (TRD) remains a major clinical challenge and is typically defined as the persistence of depressive symptoms despite at least two adequate antidepressant trials. Individuals with TRD experience substantial morbidity, impaired functioning, and elevated suicide risk, highlighting the need for therapeutic strategies beyond incremen...
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...
This scoping review aims to comprehensively map and synthesize the breadth of evidence from original research on the relationship between psilocybin and health, spanning clinical trials, epidemiological surveys, mechanistic experiments, and cross-sectional attitudinal studies. The review uses 145 references and builds its evidence map from 216 original studi...
Background: This systematic review and meta-analysis evaluates the efficacy and safety of psilocybin-assisted psychotherapy (PAP) for adults with major depressive disorder (MDD). Methods: A PROSPERO-registered search (CRD42024561979) of CENTRAL, Scopus, PsycINFO, and MEDLINE (2010-2024) identified clinical trials assessing PAP. Risk of bias was assessed usin...
The interest in psychedelics for health-related purposes has grown significantly over the past decade. However, there is an insufficient representation of stakeholders (eg, Indigenous groups, activists, policymakers) in discussions about research and regulation. Many psychedelics originate from traditional practices historically developed in low- and middle-...
Interest in psychedelics has expanded beyond clinical treatment contexts, yet little empirical work has examined how users describe psychedelic use in relation to sport and physical activity. This study conducted a qualitative content analysis of Reddit discussions involving psychedelics and physical performance. A Reddit search for “sports psychedelics” ret...
The main purpose of this study is to gain a better understanding of the distinct mental states and physical reactions that can arise during a psychedelic experience. By repeatedly assessing the same participants in an MRI while under the effects of psilocybin, the investigators want to identify reliable brain and body reactions arising during these psychedel...
The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder. Treatment-resistant depression (TRD) is a serious mental health problem in Veterans, frequently comorbid with post-traumatic str...
Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental condition in which prenatal stress and long-lasting disruptions of excitatory-inhibitory (E/I) balance have been implicated as key vulnerability factors. Although established pharmacological and behavioral treatments are effective for many individuals, they are not universally ...
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...
Abstract Background Prolonged grief disorder (PGD) is a clinically distinguishable bereavement-related condition characterized by persistent yearning, identity disruption, and impaired functioning, formalized in DSM-5-TR and ICD-11 (6L72) and empirically distinguishable from but frequently co-occurring with major depressive disorder. Approximately 7 to 10 pe...
Psilocybin, the main psychoactive compound in Psilocybe cubensis mushrooms, has gained considerable attention for its therapeutic potential. Current research focuses only on isolated psilocybin, neglecting the broader pharmacological and cultural use of the whole mushroom. This perspective advocates for an integrative approach that includes standardised P. c...
This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incur...
