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...
Psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (MDMA) have remerged as agents of psychiatric and cultural relevance. However, public discourse has outpaced empirical understanding of their effects. Although hallucinogens have demonstrated a potential to treat certain mental disorders, their effect on aggression and violen...
Psychedelic use has greatly increased within clinical and recreational settings over recent years. While demonstrating a favorable safety profile within certain clinical populations, little empirical research has explored safety of psychedelic use within real-world samples. Using the World Health Organization (WHO) VigiBase, a comprehensive global pharmacovi...
Psychedelics such as psilocybin, LSD, and MDMA have shown promise in treating mental health conditions (e.g., depression, post-traumatic stress disorder) among neurotypical individuals, i.e., typically developing individuals without a diagnosed neurodevelopmental condition. However, their therapeutic potential for treating co-occurring mental-health conditio...
This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation
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...
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with...
Introduction Psychedelic Assisted Psychotherapy (PAP) has been legal in Switzerland since 2014 under supervised exceptional medical use with MDMA, LSD and Psilocybin with case by case authorisations delivered from the Federal Office of Public Health. In particular, since 2021, we have implemented a clinical activity at Geneva University Hospital (HUG) for tr...
Introduction Mental health disorders, including depression, anxiety, and post-traumatic stress disorder (PTSD), remain a significant global health concern, requiring novel therapeutic approaches. Psilocybin, a psychedelic compound found in certain mushrooms, has shown potential in modulating neuroplasticity, a critical process for cognitive flexibility and m...
Objective: To assess the safety and efficacy of a six-week microdosing regimen of psilocybin combined with short-term, experience-based psychotherapy in patients with treatment-resistant depression who have not responded to previous pharmacological or long-term psychological interventions. Hypothesis: Compared to baseline, the group that begins with psilocyb...
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...
• Ketamine and psilocybin show promise in athlete recovery and pain management. • Psychedelics may enhance resilience, mood, and cognitive flexibility in sports. • Growing athlete use raises concerns for safety and anti-doping regulation. • Evidence on long-term effects with exercise remains scarce, urging research.
The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose i...
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....
The Hamas-led attack in southern Israel on October 7, 2023 was one of the deadliest terror attacks in history, resulting in 1,182 fatalities, over 4,000 wounded, and 251 taken hostage1. The Nova festival, an 18-hour rave held in the Gaza Envelope region, suffered the highest casualties in the attack, with over 370 killed. For the Nova attendees, the highligh...
Background/Objectives: Given the limitations of traditional approaches to treating existential distress in seriously ill patients, psilocybin-assisted therapy (PAT) has emerged as a promising treatment option. However, weighing up the potential risks and benefits of this approach can be challenging for both healthcare professionals and patients. Decision aid...
The purpose of the study is to assess the safety and acceptability of up to two sequential administrations of 25 mg psilocybin with additional therapeutic support in decreasing suicidality in patients with Bipolar Disorder (BD II) depression. This study aims to determine whether psilocybin paired with psychotherapy is a safe, feasible, and acceptable treatme...
Background: Structural inequalities in healthcare access may influence how individuals experience the psychological effects of psychedelic substances, potentially limiting positive outcomes among vulnerable populations. Objectives: This study uses data from the National Survey on Drug Use and Health (2008-2019; N = 484,732) to examine how public and private ...
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-...
