This Phase 2a clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD). The study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks) Sc...
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. The purpose of this study is to assess the feasibility, tolerability, and preliminary efficacy of psilocybin therapy for adults with chronic neuropathic pain and co-...
Introduction: Considering the increasing evidence supporting psilocybin's efficacy in therapeutic settings, it is essential to deepen our understanding of its subjective meanings and effects to enhance its integration into psychotherapy. Current knowledge is primarily based on psychometric assessments or unstructured personal reports, leaving a gap in the qu...
Adults with alcohol use disorder who received two sessions of psilocybin-assisted therapy demonstrated personality shifts toward normalization of abnormal trait expression, a secondary analysis of a randomized trial has found. A decrease in impulsiveness was found to be associated with reduced drinking post-treatment, with the strongest effect for psilocybin...
Cannabis is the most commonly used psychoactive substance in Canada (Lowry \& Corsi, 2020). A sub-group of cannabis users develop a condition known as Cannabis Use Disorder (CUD), which is defined as a regular pattern of cannabis use that causes performance difficulty at work, school and relationships (Hasin et al., 2013). A review of current treatments avai...
Psychedelics can profoundly alter consciousness by reorganising brain connectivity; however, their effects are context-sensitive. To understand how this reorganisation depends on context, we collected and comprehensively analysed the largest psychedelic neuroimaging dataset to date. Sixty-two adults were scanned with functional MRI and EEG during rest and na...
Interest in psychedelic therapies for adults is rapidly growing, with substances like 3,4-methylenedioxymethamphetamine for posttraumatic stress disorder, psilocybin for treatment-resistant depression, and lysergic acid diethylamide for generalized anxiety disorder showing promise. However, research on these therapies in children and adolescents is limited, ...
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...
ObjectivesThis scoping review aimed to synthesize the existing data about psilocybin pharmacokinetics to learn what has been described regarding body disposition and safety when psilocybin was used in controlled research settings.MethodsWe performed a scoping literature review following the framework proposed by the JBI manual for evidence synthesis. Control...
Few population-based studies have examined associations between psychedelic use and mental health outcomes. This work describes characteristics of exclusive psychedelic mushroom use (referred to as PM use), PMs in combination with other psychedelic substances (multi-psychedelic or MP) use, and non-psychedelic use and explores mental health ratings in non-cli...
Purpose of reviewThere is a mental health crisis affecting youth, and the utility of existing treatments is often limited by lack of effectiveness and tolerability. The aim of this review is to report on outcomes of clinical trials for psilocybin-assisted psychotherapy for adults with depression and MDMA-assisted psychotherapy for adults with post-traumatic ...
Background: Bipolar II disorder (BD-II) is often associated with chronic and treatment resistant major depressive episodes. Psilocybin has shown promise for its rapid-acting antidepressant effects, though its impact on bipolar depression remains unexplored. In the present subgroup analysis of an already published trial on treatment-resistant depression (TRD)...
BackgroundCannabis Use Disorder (CUD) is an increasingly prevalent disorder affecting millions of Americans each year. Psychedelic compounds have recently been investigated for their therapeutic potential in treating substance use disorders, yet no prior work has examined the relationship between naturalistic use of specific psychedelic compounds and rates o...
Fibromyalgia (FM) is the prototypical nociplastic pain condition, characterized by widespread pain and issues with cognition, mood, and sleep. Currently, there are limited treatment options available that effectively treat FM symptoms. Psilocybin-assisted therapy (PAT) is an emerging combined drug-therapy intervention, but no studies to-date have investigate...
Fibromyalgia (FM) is the prototypical nociplastic pain condition, characterized by widespread pain and issues with cognition, mood, and sleep. Currently, there are limited treatment options available that effectively treat FM symptoms. Psilocybin-assisted therapy (PAT) is an emerging combined drug-therapy intervention, but no studies to-date have investigate...
Emerging legal frameworks in Oregon and Colorado license facilitators to support adults receiving psychedelic services. The current legal frameworks are silent regarding facilitators’ personal experience with psychedelics. An eDelphi process recruited 36 experts with at least 5 years’ experience facilitating psilocybin experiences in ceremonial settings, ind...
Emerging legal frameworks in Oregon and Colorado license facilitators to support adults receiving psychedelic services. The current legal frameworks are silent regarding facilitators’ personal experience with psychedelics. An e Delphi process recruited 36 experts with at least 5 years’ experience facilitating psilocybin experiences in ceremonial settings, in...
The goal of this clinical trial is to learn if PEX010 is effective for the treatment of Stimulant Use Disorder in adults. The study will also assess the safety and feasibility of administering PEX010 to this population. The main questions it aims to answer are: Does PEX010 reduce stimulant use? What medical problems do participants experience when taking PEX...
