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...
ClinicalTrials.gov2026-02-12MycoMedica Life Sciences PBC
The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke. Stroke is the leading cause of death and adult disability worldwide, and every year more than 795,000 people in the United States have a stroke. According to the National Stroke Association, only 10 percent of people who have a st...
ClinicalTrials.gov2026-02-12Johns Hopkins University
Psychedelics' characteristic acute subjective effects predict therapeutic benefits, such as decreases in depression and anxiety. Thus, optimizing treatment involves better understanding which factors shape subjective effects. Session facilitators, who support participants before, during, and after psychedelic administration sessions, form an important part o...
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...
ClinicalTrials.gov2026-02-11Centre for Addiction and Mental Health
Abstract Background and aims Despite growing popularity and increasing legal access, psychedelic therapy remains financially inaccessible to many. This study was designed to test the feasibility of conducting group psilocybin therapy in low-income adults with depression in Oregon's regulated psilocybin program. Methods An open label, uncontrolled design was ...
Abstract Rapid-acting antidepressants like ketamine and serotonergic psychedelics show promise for treatment-resistant depression (TRD), but the molecular mechanisms that contribute to their therapeutic effects remain unclear. Induced pluripotent stem cells (iPSCs) offer a platform to model human cortical neurons and investigate drug effects in a human-relev...
Research Square2026-02-11Johnston J, Jones G, Peng S, Yuan P, Yavi M, Kadriu B, Henter I, Quintanilla B, Elkahloun AG, Moaddel R, Schulmann A, Akula N, Kvarta M, McMahon F, Zarate C.
Europe PMCPREPRINT (not peer reviewed)psilocybinDepressionNeuroplasticityMechanism of ActionClinical TrialHealthy VolunteersTreatment-Resistant DepressionTranscriptomicsProteomicsInflammationClinical Trial
BACKGROUND: Several recent trials indicate positive effects of psilocybin in patients with major depressive disorder. However, questions need to be addressed regarding the relationship between dosage and therapeutic outcomes, such as the recommended dose range and frequency for optimal practice as well as the dose-dependent adverse effects. OBJECTIVE: (1) to...
Anhedonia, a core symptom of depression, is often resistant to conventional treatments and significantly impacts quality of life. This secondary analysis aimed to evaluate the effects of psilocybin-assisted psychotherapy (PAP) on anhedonia severity in individuals with treatment-resistant depression (TRD). Participants (n = 30) with TRD and a primary diagnosi...
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...
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...
Electroencephalography (EEG) recently celebrated its 100-year anniversary, having revolutionized the study of cognitive function across species. Over the past century, neuroelectric measures such as resting-state EEG, event-related potentials (ERP), and event-related oscillations (ERO) have become indispensable not only for advancing our understanding of bra...
Background: Informed consent in psychedelic-assisted services is ethically complex, difficult to implement, and remains largely unstudied and unstandardized. Objective: The current study sought expert recommendations from experienced psychedelic facilitators on what constitutes informed consent best practices for supervised psychedelic experiences across var...
Functional disorders, characterised by symptoms unexplained by organic disease, impose a significant burden on individuals and healthcare systems. Existing treatments are limited in efficacy, with no effective pharmacotherapies. There is growing evidence supporting the treatment potential of psychedelics in neuropsychiatric conditions, including several dist...
The goal of this open-label, dose-escalation, prospective study is to evaluate the safety and psychological effects of a Psilocybin and D-Serine formulation in healthy volunteers. The main objectives are: 1. To assess the psychological and physiological effects of psilocybin administered with D-Serine in healthy adults. 2. To determine whether D-Serine modul...
ClinicalTrials.gov2026-02-04Hadassah Medical Organization
Participants with IBS (all subtypes) and with no exclusionary comorbid psychiatric or medical disorders will be enrolled in the study. This study will involve a randomized waitlist control design to investigate the rapid and sustained effects of TRP-8802 following two experimental sessions in which an oral dose of TRP-8802 is administered to participants wit...
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...
ClinicalTrials.gov2026-02-04Nantes University Hospital
ClinicalTrials.govCLINICAL TRIALpsilocybinClinical TrialSafetyClinical TrialGambling DisorderPsychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate)
Serotonergic psychedelics, such as lysergic acid diethylamide, and psilocybin, and the entactogen 3,4-methylenedioxymethamphetamine exhibit agonist activity at the 5-hydroxytryptamine 2B receptor, a signalling pathway known to mechanistically mediate drug-induced valvular heart disease. This systematic review evaluates whether chronic or repeated use of psyc...
RationaleClassical psychedelics-a broad class of compounds that include psilocybin, lysergic acid diethylamide, dimethyltryptamine, and mescaline-have shown significant promise for the treatment of mental health conditions in recent clinical trials. Organizations such as the National Network of Depression Centers (NNDCs) can play a pivotal role in uniting re...
