About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress. Treatment options such as medication and therapy are available; however, they do not always work and can be time-consuming and expensive. We need treatments that work well, quickly, and ...
The goal of this multi-centre phase I/II open-label, single-arm study is to determine the safety, feasibility, therapeutic dose, and preliminary efficacy of psilocybin microdosing to treat psychological distress among patients with advanced illness. Forty patients will receive psilocybin drug product (1-3mg per day, Mon-Fri) for 4 weeks to be administered vi...
Importance: The Oregon Psilocybin Services (OPS) program is the first statewide, regulated framework for legal psilocybin in the U.S. Analyzing inaugural-year utilization and safety is essential for informing policy and equity monitoring. Methods: We conducted a descriptive analysis of statewide aggregate data from the OPS Public Dashboard (January 1-Decembe...
This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active placebo (1 mg micro-dose) psilocybin-assisted therapy in...
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...
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 ...
Importance: The availability of psychedelic retreats has grown to meet the demand for access to these substances. Despite centuries of use among Indigenous communities, psychedelics can pose serious risks for some users. Objective: To determine safety precautions that retreat organizations that offer psychedelic substances currently use. Design, Setting, and...
Nicotine dependence remains a leading cause of preventable mortality worldwide. Pharmacotherapy and behavioral interventions offer modest efficacy with limited long-term success. Psilocybin-assisted psychotherapy (PAP) is an emerging approach to nicotine cessation with a growing evidence base. As PAP research expands, understanding how nicotine users’ attitu...
Psychedelics such as psilocybin, LSD, and MDMA have shown promise in treating mental health conditions (e.g., depression, post-traumatic stress disorder) among neurotypical individuals, i.e., typically developing individuals without a diagnosed neurodevelopmental condition. However, their therapeutic potential for treating co-occurring mental-health conditio...
Metastability of BOLD fMRI signals is a commonly used proxy of brain dynamics in behavioral and clinical studies. To date, little has been done to assess the confidence with which we can use estimates of metastability as reliable biomarkers of individual brain state. We analyze whole-brain and network-specific metastability for a highly sampled individual br...
BACKGROUND: Psilocybin-assisted psychotherapy (PAP) has gained attention as a promising intervention for conditions including depression, anxiety and post-traumatic stress disorder, but understanding of its side-effects is limited. This review evaluates the quality of side-effects reporting in PAP trials, to guide treatment, policy and research. AIMS: To ass...
OBJECTIVE: Despite growing research on the potential mental health benefits of psychedelics, there has been limited study of these drugs in populations with obsessive-compulsive disorder (OCD) and with Hispanic and Latin American (H/L) ancestry. METHODS: Demographic and clinical assessments were conducted as part of the Latin American Trans-ancestry Initiati...
BACKGROUND: Depression and burnout, which are common among healthcare workers, were exacerbated by the COVID-19 pandemic. Mindfulness-Based Stress Reduction (MBSR) and psilocybin have been reported to reduce depressive symptoms, but the efficacy of the combination requires comparison to an active treatment control. We sought to evaluate the safety and prelim...
Background: Cancer poses an existential threat for patients and caregivers. Psilocybin-assisted therapy (PAT) has emerged as a potential tool to meet these existential needs, yet little is known about how patients describe this element of their cancer journey, and how it might be affected by PAT, especially in the group therapy context. Purpose: To explore h...
This viewpoint reconceptualizes mysticism and fundamentalism as brain network disorders, with psychedelics like psilocybin, lysergic acid diethylamide, and N,N-dimethyltryptamine offering potential to modulate these states. By disrupting rigid neural patterns, psychedelics may foster cognitive flexibility, challenge inflexible belief systems, and offer thera...
Neurobiological effects and psychological models propose that psychedelics may promote psychological flexibility, suggesting a transdiagnostic effect by disrupting maladaptive patterns. The objective of this study was therefore to investigate the determinants of psychological flexibility change following a psychedelic use. This retrospective online survey in...
