Introduction Psychoactive Psilocybe spp. mushrooms pose significant public health risks. We report a cluster of Psilocybe keralensis poisonings in Chengdu, China, highlighting its unique clinical features and cardiovascular complications.Case Series Four patients ingested 16-90 g of wild mushrooms (misidentified as an edible species, but later molecularly co...
Background: Depressive disorders are a major global health challenge, with many individuals unresponsive to existing treatments. Novel psychedelic therapies show promise but require further research. Objectives: This study aimed to evaluate the feasibility, safety and effectiveness of psilocybin with psychotherapeutic support for treatment-resistant depressi...
Background: Post-traumatic stress disorder (PTSD) is a debilitating condition for which there are few efficacious treatments. Psilocybin is being studied for use in treatment-resistant depression but has not yet been investigated in PTSD. Aims: The trial’s primary outcome was to investigate the safety and tolerability of single-dose psilocybin in participant...
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for treatment of approximately 40 military veterans and first responders (ages 21-65) with co-occurring alcohol use disorder (AUD) and post...
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...
IMPORTANCE: Psilocybin-assisted psychotherapy may offer a novel approach to treating depression, anxiety, and existential distress in individuals with life threatening illnesses, where current treatments show limited efficacy. OBJECTIVE: To evaluate the efficacy and safety of psilocybin-assisted psychotherapy versus active placebo and psychotherapy in adults...
Use of selective serotonin reuptake inhibitor (SSRI) antidepressants has been associated with reduced intensity of emotional experience. Conversely, some research has shown that use of psilocybin in patients with depression leads to an increase in responsiveness to emotional face stimuli, suggesting that the psychedelic generates a transient elevation in moo...
This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care outpatient buprenorphine treatment for Opioid use disorder (OUD). The participants will have previously undergone buprenorphine induction before. Effects of adjunctive psilocy...
BACKGROUND AND AIMS: Psilocybin has emerged as a potential treatment for alcohol use disorder (AUD), but early efficacy data are inconsistent. Depression following alcohol detoxification significantly increases the risk of relapse. This pilot study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of psilocybin-assisted psychotherapy...
BackgroundResearch into psychedelics has gained renewed interest due to their potential to address psychiatric, neurological, and other peripheral conditions. These substances offer long-term therapeutic benefits, contrasting with the side effects and limitations of current psychiatric medicines.ObjectiveThis study examines the legislations and regulatory fr...
ImportancePsilocybin has demonstrated rapid and sustained antidepressant efficacy, with acute-phase effect sizes often more than double those for conventional antidepressants. However, concerns have been raised that high rates of functional unblinding in combination with trial participants with positive expectations of psychedelic use might bias treatment ou...
BACKGROUND: Patients with cancer often struggle with depression, which can negatively impact quality of life as well as be challenging to manage. METHODS: A phase 2 trial was conducted that demonstrated safety, feasibility, and efficacy of a single dose of psilocybin combined with psychological support in a community cancer setting in 30 patients with cancer...
The goal of this clinical trial is to test the feasibility of combining meditation with psilocybin microdosing in healthy adults. The main questions it aims to answer are: 1. Recruitment and retention feasibility 2. Acceptability, Safety and Tolerability 3. Exploratory Measures: 3.1: Explore potential changes in sleep quality and duration, heart rate variabi...
Psilocybin (PSIL) is a psychedelic drug and a promising experimental therapeutic for many psychiatric conditions. Precision functional mapping (PFM) combines densely repeated resting state fMRI sampling and individual-specific network mapping to improve signal-to-noise ratio (SNR) and effect size in brain imaging research. We present a randomized cross-over ...
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...
We present divergent experiences of 2 patients who participated in a clinical trial of psilocybin-assisted cognitive behavioral therapy for major depressive disorder. Both patients participated in an open trial involving 2 drug administration sessions separated by one month (10 and 25 mg, respectively) along with 12 sessions of cognitive behavioral therapy...
Psilocybin therapy (PT) is emerging as an effective intervention for Major Depressive Disorder (MDD), offering comparable efficacy to conventional treatments like selective serotonin reuptake inhibitors (SSRIs). Music, an emotionally evocative stimulus, provides a valuable tool to explore changes in hedonic and predictive processing mechanisms via expectancy...
Objective To evaluate psilocybin's efficacy in reducing depressive and anxiety symptoms in cancer patients based on randomized controlled trials (RCTs). Methods This systematic review and network meta-analysis (NMA) followed PRISMA and Cochrane Handbook guidelines. PubMed, Embase and Cochrane Library data up to July 2024 were analyzed. Two RCTs met the inclu...
