The primary objective of this study is to evaluate the ability to recruit and retain participants, and to successfully conduct a psilocybin-based protocol, for a study of the treatment of distress related to stage IV or inoperable gastrointestinal cancers. Secondary objectives include pre/post, and longitudinal measurement of distress in intervention partici...
This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent were enrolled into this study and completed web surveys and telephone interviews conducted by one central site at the following time intervals: months 3 and 6 (± 7 days for each assessment) and months 10 and 12 (...
In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinic...
This is an observational study which does NOT directly administer a psychedelic substance but rather recruits participants who are already participating in another clinical trial in which they may receive a serotonergic psychedelic. The goal of this observational study is to learn how the brain's information processing changes during and following administra...
AbstractIntroduction Psilocybin, a naturally occurring psychedelic compound found in certain mushroom species, has gained substantial clinical, scientific, and cultural attention in recent years. Despite this growing interest and evolving policy landscape, nationally representative estimates of recent psilocybin use in the United States remain limited. Under...
Abstract Introduction Psychedelic use and interest in its therapeutic potential are rapidly increasing; yet its relationship with insomnia remains poorly understood. This study aims to estimate differences in insomnia severity by type of psychedelic consumed among a cohort of 18-to-35-year olds. Methods Data are from the Herbal Heart Study - Sleep Ancillary ...
While psychedelics have shown initial promise in the treatment of migraine, experimental studies have relied on small and homogenous samples, which limit the reliability and generalizability of findings. These limitations underscore the complementary value of other research designs that leverage larger and more representative samples. This cross-sectional st...
PurposeTo examine the prevalence of lifetime ("ever") cannabis and classic psychedelic use, and their co-use among U.S. adults aged ≥ 50 years with versus without a lifetime history of cancer, and to describe variation by cancer type/site among survivors.MethodsWe analyzed pooled 2015-2019 and 2021-2022 National Survey on Drug Use and Health (NSDUH) data of ...
The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depr...
This systematic review and meta-analysis synthesized data from 13 clinical trials (n=606) evaluating psilocybin-assisted psychotherapy for major depressive disorder and treatment-resistant depression. Despite early enthusiasm, the pooled standardized mean difference (-0.79, 95% confidence interval: -3.98 to 2.40, p=0.63) revealed no statistically significant...
Background Obsessive-Compulsive Disorder (OCD) can present significant challenges to individuals mental health, characterized by intrusive thoughts and repetitive maladaptive behaviors. Recent research into alternative treatments has highlighted psychedelics, notably psilocybin, for their potential therapeutic benefits in various psychiatric disorders, inclu...
Abstract Background and aims Psilocybin, a psychoactive compound found in fungi commonly referred to as “magic mushrooms,” is consumed for both spiritual and recreational purposes. However, psilocybin use in Puerto Rico remains understudied. This exploratory cross-sectional survey aimed to describe patterns of use, motivations for consumption, explanatory fa...
Background: Psilocybin-assisted therapy (PAT) has shown promise for alcohol use disorder (AUD) in randomized controlled trials (RCTs). However, the effects of open-label administration following blinded treatment are unclear. Here, we present safety and efficacy data from an open-label extension of a Phase II RCT (NCT02061293) examining PAT for AUD. Methods:...
PRE-EMPT will assemble a study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). The teams will then administer three interventions (neurofeedback, transcranial magnetic stimulat...
Psilocybin, N,N-dimethyltryptamine (DMT), lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (MDMA) are psychedelic compounds with therapeutic potential for depression, anxiety, and post-traumatic stress. However, their relevance to endurance athletes, who face particular psychological and physical stressors, remains underexplored. This ...
The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that limit functionality) in the treatment of mo...
BACKGROUND: New legal frameworks for supervised psychedelic services are emerging, with Oregon and Colorado implementing programs to train and license psilocybin facilitators. This study describes Oregon's early psilocybin facilitator workforce and assesses state-approved training programs. METHODS: The Open Psychedelic Evaluation Nexus (OPEN) reviewed Orego...
Abstract Depression and anxiety affect one in five adults, with age affecting prevalence. While clinical trials suggest classic psychedelics (e.g., psilocybin, LSD) and non-classic psychedelics (e.g., MDMA, ketamine) may alleviate these symptoms, it remains unclear how these relationships function in naturalistic settings or how they vary across the lifespan...
BACKGROUND AND AIMS: There has been a resurgence of interest in using psilocybin to treat various mental health conditions. Although some adults in the United States (US) are using psilocybin, little is known about the epidemiology of its use, especially for microdosing (i.e., taking a fraction of a regular dose). This study aimed to present nationally repre...
