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 ...
Psychedelics have emerged as potential therapeutics for substance use disorders, yet preclinical data validating their efficacy remain limited. Here, we investigated the effects of a clinically inspired dose-escalation protocol of psilocybin and ibogaine on extinction and cue-induced reinstatement in Wistar male rats following intravenous cocaine self-admini...
The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomized clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder. Feasibility will be assessed by estimating the ability to retain participants until the end of the protocol. Other objectives of the study will be to generate prelimi...
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 principal investigator for this study plans to build upon the psilocybin-assisted therapy intervention used in prior completed trials to conduct an open-label trial of two psilocybin administration sessions combined with psychotherapy to investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of PTSD i...
Objective: Emerging evidence suggests that mystical experiences mediate the therapeutic effects of psychedelic-assisted therapy. The current study examines associations between mystical experiences and components of “set” (positive mindset, participant intentions, and spirituality) and “setting” (perceived positivity of the dosing environment) in the context...
This trial aims to examine the safety and efficacy of small (2mg) sub-hallucinogenic doses of psilocybin in people with Major Depressive Disorder. This protocol is for a University of Toronto - sponsored, randomized, placebo-controlled crossover phase 2 study of the safety and efficacy of low doses of psilocybin in subjects with depressive symptoms who meet ...
Eating disorders (ED) remain challenging to treat, with high dropout and low remission rates in cognitive-behavioral therapy for EDs (CBT-ED). Psilocybin treatment (PT) demonstrates therapeutic potential to enhance CBT-ED by exerting several neurobiological, psychological, and experiential effects (e.g., antidepressant, neuroplasticity, emotional openness) t...
BACKGROUND: Obsessive-compulsive disorder (OCD) is a debilitating mental disorder commonly treated with selective serotonin reuptake inhibitors, atypical antipsychotic augmentation and cognitive-behavioural therapy. However, up to 60% of people with OCD do not respond to these treatments. Therefore, a novel intervention, psilocybin-assisted psychotherapy (PA...
The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder. This will be a phase II 2x2 design (device and dose) clinical trial. 100 participant...
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals. Individuals with OCD often have diminished quality of life, and functional impairment. The disorder cause high personal, societal and economic costs. Current availab...
Psychedelic mushrooms of the Psilocybe genus contain the psychoactive tryptamines psilocybin and psilocin, compounds currently under clinical investigation for the treatment of depression and other psychiatric conditions. However, the accurate quantification of these alkaloids in fungal matrices remains analytically challenging. Here, we report an optimized ...
High Resolution Image Download MS PowerPoint Slide Psychedelic mushrooms of the Psilocybe genus contain the psychoactive tryptamines psilocybin and psilocin, compounds currently under clinical investigation for the treatment of depression and other psychiatric conditions. However, the accurate quantification of these alkaloids in fungal matrices remains anal...
Background/importanceChronic pain affects many people globally, requiring alternative management strategies. Psilocybin is gaining attention for its potential in chronic pain management despite being classified as Schedule I.ObjectiveThis systematic review critically evaluates the evidence for psilocybin, a Schedule I substance, in the treatment of chronic p...
BACKGROUND: Motor functional neurological disorder (FND) is a common illness associated with significant functional impairment. There are no effective pharmacotherapies, and despite the early promise of physiotherapy studies, many suffer disabling symptoms in the long term. There is a theoretical rationale for combining psychedelics with physiotherapy; howev...
BACKGROUND: Individuals with advanced cancer often experience high levels of distress for which there are few standardized treatment approaches. Our multidisciplinary team has combined existing evidence-based approaches into Psilocybin-assisted Existential, Attachment, and RelationaL (PEARL) therapy. PEARL therapy combines elements from psilocybin-assisted p...
BackgroundResults from contemporary clinical trials of serotonergic psychedelic therapies have led to an increasing focus on their potential clinical use across mental disorders. However, studies examining mechanisms of clinical response to psychedelic therapy in psychiatric populations are limited. This review aimed to synthesize evidence from studies exami...
The primary purpose of this study is to preliminarily determine if the use of psilocybin to promote abstinence from methamphetamine is feasible and well tolerated in populations such as those found in Northern Louisiana. Investigators will assess the impact of psilocybin-facilitated treatment on methamphetamine abstinence, craving, negative affect, cognitive...
Psilocybin, an indoleamine alkaloid derived from various fungal species, is the subject of renewed, rigorous investigation for its therapeutic potential in psychiatry. This compound, a prodrug for the active metabolite psilocin, functions primarily as a partial agonist at the serotonin 2A (5-HT2A) receptor. Its administration within a structured psychotherap...
Supplement 1. Additional tables presenting primary and secondary outcomes, sensitivity analyses, and exploratory findings. Table A1. ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table A2. Adjusted ITT analyses for QIDS-SR-16 and MBI-HSS-MP. Table B1. Intent-To-Treat (ITT) Analysis for Demoralization Scale (DSII) and PTSD Checklist for DSM-5 (PCL-5). Table B2....
