MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this trial is to investigate brain activity, safety, tolerability, and PK of multiple doses of MLS101 in healthy participants. In recent years, high-dose psilocybin has gained attention for it potential therapeutic ben...
The goal of this clinical trial is to evaluate whether a single dose of psilocybin is feasible and safe for adults with opioid use disorder (OUD) who are recovering from trauma surgery. The main questions it aims to answer are: 1. Is a single psilocybin dose feasible to administer during postoperative hospitalization? 2. Is psilocybin safe in this patient po...
The goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). The main question it aims to answer is: \- What is the feasibility and safety of administering PAT in adults with MDD-AUD by evaluating recruitment, retention...
Background: Psilocybin treatment has shown promise across a range of psychiatric conditions. Mystical-type experiences during dosing sessions have been shown to predict the clinical effects of psilocybin treatment in depression, anxiety, and addiction. However, no studies have examined whether acute subjective experiences predict treatment response in obsess...
This is a double-blind, adaptive, 2-stage, multi-site, phase 2 randomized controlled clinical trial designed to evaluate effects of moderate and high dose psilocybin, relative to low-dose psilocybin control, in OUD patients who continue to use illicit opioids in spite of adherence to standard-of-care treatment with methadone. Up to 480 participations will be...
The escalating global burden of mental health disorders, coupled with the stagnation of innovation in traditional monoaminergic pharmacotherapy (e.g., SSRIs), has precipitated a critical need for novel therapeutic paradigms. This article presents a comprehensive systematic review of the so-called "Psychedelic Renaissance," focusing on the clinical resurgence...
Psilocybin therapy shows potential benefits for mental health conditions such as depression and substance use disorders, though further research is needed to confirm long-term safety and efficacy.
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 systematic review evaluates the efficacy and safety of psilocybin in the treatment of depressive disorders in adult populations, including major depressive disorder and treatment-resistant depression. PRISMA guidelines were followed to identify and analyze clinical trials comparing psilocybin with different control conditions. Variables related to the r...
Psilocybe cubensis mushrooms are typically not consumed for their nutritional value. The main reason people ingest these mushrooms is for their psychoactive effects. Recently, there has been growing interest in the potential therapeutic applications of psilocybin-containing mushrooms in a range of psychiatric conditions, including depression, anxiety disorde...
There remain significant gaps in knowledge about best practices for facilitated psychedelic care and psychedelic-assisted therapy. To inform the development of service models that support safe and beneficial experiences, this qualitative study explored expert perspectives on current and ideal standards of care, including key practices (e.g., screening, adapt...
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...
OBJECTIVE: Anxiety is common in patients receiving end-of-life care and significantly impacts their quality of life. However, pharmacological management remains challenging due to complex clinical presentations and potential side effects, emphasizing the need for systematically reviewing existing treatments. Here we aim to systematically evaluate the efficac...
Abstract Recent clinical breakthroughs hold great promise for the application of psilocybin in the treatments of psychological disorders, such as depression, addiction, and obsessive-compulsive disorder. Psilocybin is a psychedelic whose metabolite, psilocin, is a 5-HT2A receptor agonist. Nevertheless, the underlying mechanisms for the effects of psilocybin ...
Classic psychedelics such as psilocybin, lysergic acid diethylamide (LSD), and 5-methoxy-dimethyltryptamine (5-MeO-DMT) have shown promising effects in the treatment of certain mental health conditions. Enthusiastic claims about their therapeutic potential have led to overly optimistic reactions in the media and the public, subsequently resulting in increase...
Major depressive disorder (MDD) continues to pose a major therapeutic challenge due to its clinical heterogeneity. This chapter looks at the development of antidepressant treatments, starting with early interventions such as electroconvulsive therapy (ECT), monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs). Although these treatments t...
The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes. Preclinical and human stud...
Background: Psychedelic-assisted psychotherapy has shown promising results for treating alcohol use disorder (AUD) and other mental health conditions. Although the precise mechanisms of psychedelic therapies remain unclear, many studies report increased feelings of connectedness following psychedelic experiences. Specifically, both nature relatedness (one’s ...
