ABSTRACT Clinical trials suggest that a single dose of psilocybin is an effective treatment for substance use disorders (SUDs). Choice impulsivity is a value-based decision-making bias that predicts drug-intake escalation and is commonly associated with SUDs. The dorsomedial prefrontal cortex (dmPFC) regulates choice impulsivity and is enriched with 5-HT2A r...
BackgroundThe Altered States of Consciousness Scale (3/5D-ASC or 11-ASC) is widely used to assess non-ordinary states of consciousness, particularly for psychedelic research. However, its original dimensional model (3D-ASC within 5D-ASC) and later 11-subscale structure (11-ASC) have a hierarchically incompatible higher/lower-order structure. Although the 11-...
Background Psychedelics exert widespread effects on brain activity, but their impact on motor function is unclear. This is clinically relevant given the emerging interest in psychedelic-assisted physical therapy for disorders of motor function. This study’s primary objectives examined the feasibility and safety of administering movement tasks following low-t...
This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of psilocybin as a therapeutic intervention for adults with developmental stuttering. This pilot study will assess whether further research to explore the potential benefits of psilocybin-assisted the...
Psilocybin, a naturally occurring tryptamine alkaloid found in over 200 species of fungi, has emerged as a focal point in the modern revival of psychedelic science. Once relegated to the margins of psychopharmacology due to its association with counterculture and strict legal restrictions, psilocybin is now undergoing a scientific renaissance. This transform...
This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary ai...
Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD) This is a phase III, international, multi-centre, randomised, parallel group, fixed single-dose, double-blind, placebo-controlled study. The study population will include participants aged ≥18 years with TRD. Overall, 255 partici...
OBJECTIVES: Interest in psilocybin as a treatment for depression has risen over the past decade, fuelled by promising clinical trials and a rapidly evolving regulatory landscape. Media coverage plays a critical role in shaping public perceptions, yet little is known about how psilocybin is portrayed in global anglophone online news for the treatment of depre...
Australia's reclassification of psilocybin as a Schedule 8 substance for treatment-resistant depression represents a significant shift in psychiatric policy. While this regulatory change positions Australia as a global leader in psychedelic medicine, its implementation has revealed substantial challenges. This article critically examines the regulatory, ethi...
The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer. The name of the study intervention used in this research study is: Psilocybin (a tryptamine derivative) This study is a phase 2 open label, single center, concur...
Abstract Psilocybin has demonstrated promising antidepressant effects in depression and treatment-resistant depression (TRD) in controlled clinical trials. However, its effectiveness and safety in real-world therapeutic settings remain largely unknown. Although psilocybin is not yet approved as an antidepressant treatment, Switzerland’s unique legal framewor...
Introduction: The subjective effects of psilocybin on obsessive-compulsive disorder (OCD) are under-explored. Therefore, we conducted a qualitative study of participant experiences from the first randomized placebo-controlled trial of single-dose psilocybin combined with unstructured and non-directive support for individuals with treatment-refractory OCD. Ou...
Alcohol use disorder is a psychiatric condition characterized by excessive alcohol consumption. The drugs that are used to treat it often fail to prevent relapse. At the same time, psilocybin is increasingly being investigated for the treatment of various substance use disorders. This review aims to evaluate the results of the most recent clinical trials ass...
The global demographic shift toward aging populations has intensified the need for innovative therapeutic interventions targeting late-life mental health conditions, notably depression, loneliness, and existential distress. Traditional pharmacological treatments often exhibit limited efficacy and poor tolerability in older patients, primarily due to age-rela...
PURPOSE/BACKGROUND: The therapeutic effects of psilocybin treatment are thought to be influenced by the subjective dose-dependent psychedelic experience, as well as the individual participant's mindset and the treatment environment. However, the relative contribution of an individual's pretreatment clinical characteristics and their subjective psychedelic ex...
This is an open-label pilot trial to assess the safety and feasibility of a novel 8-week psilocybin-assisted psychotherapy intervention to facilitate successful tapering/discontinuation of opioid pain medication in adult patients receiving long-term opioid therapy for chronic pain. Participation will last approximately 8 months and includes one or two psiloc...
In 1970, Congress passed the Controlled Substances Act and swiftly placed psilocybin (the active chemical in “magic mushrooms”) under Schedule I-the strictest level of regulation withheld for substances with “no currently accepted medical use.” While the United States has maintained this rigid framework, Jamaica has taken the opposite approach. Psilocybin wa...
Background: Post-traumatic stress disorder (PTSD) is a debilitating condition leading to significant personal and societal burden. Standard treatments frequently demonstrate limited efficacy, leading to persistent symptoms and high dropout rates. Psilocybin has shown promise in treating depression, a condition that is often comorbid with PTSD. We aimed to ex...
This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of psilocybin. Arm 2...