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Executed search Journal: ClinicalTrials.gov 287 matching records are displayed.

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287 matching results

A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder

Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder. This is a phase II, multi-centre, randomised, double-blind, controlled study. The study population will include participants aged ≥18 years with recurrent Major Depressive Disorder (MDD) with up to four prior tre...

ClinicalTrials.gov 2025-08-18 COMPASS Pathways

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionPharmacologyClinical TrialSafety Clinical Trial Major Depressive DisorderPsilocybin

Outpatient Buprenorphine Induction With Psilocybin for Opioid Use Disorder: a Randomized Double-blind Trial

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...

ClinicalTrials.gov 2025-07-27 Johns Hopkins University

ClinicalTrials.gov CLINICAL TRIAL psilocybin AddictionPharmacologyClinical TrialRandomized Controlled TrialHealthy VolunteersHealthcare WorkersAdverse Events Randomized Controlled Trial Opioid Use DisorderPsilocybin

Modulation of Serotonin Pathways Using Psilocybin in Adults With and Without Autism Spectrum Disorder (ASD)

This study will test the hypothesis that brain systems are differentially regulated by serotonin in individuals with and without Autism Spectrum Disorder. To do this, the brain response to two single acute doses of partial serotonin (5HT)1A/2A receptor agonist psilocybin (COMP360) relative to a single dose of placebo (baseline serotonin activity) will be com...

ClinicalTrials.gov 2025-07-27 King's College London

ClinicalTrials.gov CLINICAL TRIAL psilocybin Brain ImagingMechanism of ActionReceptor PharmacologyClinical TrialReview Article Clinical Trial Autism Spectrum DisorderPsilocybin 5 mg

Mechanistic Studies of Psilocybin in Headache Disorders

In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflam...

ClinicalTrials.gov 2025-07-23 Yale University

ClinicalTrials.gov CLINICAL TRIAL psilocybin Headache / MigraineNeuroplasticityBrain ImagingBiomarkersClinical TrialInflammation Clinical Trial MigrainePsilocybin

The Safety, Feasibility, and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain (P-PC)

This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with demoralization and chronic pain. Cancer patients often experience demoralization, which is characterized by feelings of hopelessness, loss of meaning, and existential distress. Psilocybin psychotherapy, together w...

ClinicalTrials.gov 2025-07-22 Emory University

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyEnd-of-Life DistressChronic PainMystical ExperienceClinical TrialCancer PatientsSafetyAdverse Events Clinical Trial Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality

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...

ClinicalTrials.gov 2025-07-17 The University of Texas Health Science Center, Houston

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionClinical TrialSafety Clinical Trial Bipolar II DisorderDepression

Visual Surround Suppression and Perceptual Expectation Under Psilocybin

The prospective pilot study will address the critical need for more precise characterizations of the acute visual effects of the drug psilocybin by measuring the impact of acute psilocybin intoxication on a perceptual task known as visual surround suppression, compared to an active placebo control. The proposed pilot study will address the critical need for ...

ClinicalTrials.gov 2025-06-26 University of Minnesota

ClinicalTrials.gov CLINICAL TRIAL psilocybin Mechanism of Action Other Perception DisturbanceVisual Suppression

The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder The Safety and Tolerability of COMP360 administered under supportive conditions in participants with Post-traumatic Stress Disorder

ClinicalTrials.gov 2025-06-12 COMPASS Pathways

ClinicalTrials.gov CLINICAL TRIAL psilocybin PTSDSafety Other Post Traumatic Stress DisorderPsilocybin

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 (Psilocybin) in Healthy Participants

MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy, adult particip...

ClinicalTrials.gov 2025-06-11 MycoMedica Life Sciences PBC

ClinicalTrials.gov CLINICAL TRIAL psilocybin PharmacologyMicrodosingClinical TrialHealthy VolunteersSafety Clinical Trial Healthy VolunteersPsilocybin

Comparison of the Effects of PEX20 (Oral Psilocin), PEX30 (Sublingual Psilocin), and PEX10 (Oral Psilocybin) in Healthy Adults

To compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults. The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the to...

ClinicalTrials.gov 2025-06-09 University of California, San Francisco

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin Healthcare WorkersSafety Other HealthyPsilocin

Psilocybin With Intracranial Neural Sensing

This is an open-label, single-arm, pilot study exploring the neural, sensory, and cognitive effects of a single, medium dose of psilocybin in patients with chronic pain who already have implanted sensing-capable deep brain stimulation (DBS) devices. Outcomes include multi-site neural recording from previously placed ambulatory sensing-capable DBS devices, qu...

ClinicalTrials.gov 2025-06-05 Joshua Woolley, MD, PhD

ClinicalTrials.gov CLINICAL TRIAL psilocybin Chronic Pain Other Chronic PainPsilocybin

Low-Income Group Psilocybin Assisted Therapy for Depression: A Feasibility Study

Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date h...

ClinicalTrials.gov 2025-06-04 Matthew Hicks

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionMechanism of ActionConsciousnessClinical TrialObservational StudySafety Clinical Trial DepressionPsilocybin

Optimizing Microdosing and Meditation

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...

ClinicalTrials.gov 2025-06-04 National University of Natural Medicine

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAddictionConsciousnessMicrodosingWellbeingClinical TrialReview ArticleObservational StudySafetyAdverse Events Clinical Trial MeditationMicrodosing

Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD)

This study will examine the synaptotrophic effects of psilocybin among medically healthy, detoxified OUD subjects. Eligible OUD participants will undergo pre- and post- psilocybin administration PET scans with the \[11C\]-UCB-J radiotracer while inpatient. Participants will undergo screening as outpatients at the Clinical Neuroscience Research Unit (CNRU). O...

ClinicalTrials.gov 2025-05-28 Yale University

ClinicalTrials.gov CLINICAL TRIAL psilocybin AddictionBrain ImagingAgingToxicity Other Opioid Use DisorderPsilocybin

Role of the Serotonin 2A Receptor in Psilocybin-induced Altered States of Consciousness (PDR-Study)

Psilocybin (active compound of "magic mushrooms") is a prototypical psychedelic substance that acts via agonism on serotonin (5-HT) 2A receptors. Psilocybin is rapidly metabolized into its active metabolite psilocin. Psilocybin is currently under investigation as potential treatment for various neuropsychiatric disorders. Psilocybin is also widely used for r...

ClinicalTrials.gov 2025-05-27 University Hospital, Basel, Switzerland

ClinicalTrials.gov CLINICAL TRIAL psilocybinpsilocin DepressionAnxietyAddictionReceptor PharmacologyConsciousnessPersonality ChangeSpiritualityHealthy Volunteers Other HealthyKetanserin 40mg plus Psilocybin 40mg

Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study

One of the most promising lines of investigation for the therapeutic use of hallucinogens in the 1960s and 1970s was in the treatment of drug dependence. The investigators propose to examine psilocybin administration combined with a structured smoking cessation treatment program in nicotine dependent individuals in order to provide preliminary data on the ef...

ClinicalTrials.gov 2025-05-24 Johns Hopkins University

ClinicalTrials.gov CLINICAL TRIAL psilocybin AddictionMechanism of ActionSpiritualityRandomized Controlled Trial Randomized Controlled Trial Nicotine DependencePsilocybin-assisted treatment

An Investigation of Strategies to Understand and Optimize the Antidepressant Effects of Psilocybin (The OPTIMIZE Study)

This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In...

ClinicalTrials.gov 2025-05-22 Charles Raison

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionAnxietyAgingWellbeingAdverse Events Clinical Trial DepressionPsilocybin

Consciousness and Psilocybin Effects on Well-Being (The CoPE Study): Pilot Phase

This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them. The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes. Subsequently, the pre-treatment of 0.2 mg o...

ClinicalTrials.gov 2025-05-15 University of Wisconsin, Madison

ClinicalTrials.gov CLINICAL TRIAL psilocybin ConsciousnessWellbeing Clinical Trial HealthyPsychedelic Experiences

Investigating the Role of Serotonin in the Mechanism of Action of Psilocybin in Patients With Major Depressive Disorder

This is an interventional, parallel arm assignment treatment study in individuals with Major Depressive Disorder (MDD). Each individual will be treated with a single dose of pimavanserin or placebo plus a single dose of psilocybin. Evaluations will be taken before dosing and following dosing at several timepoints up to 5 weeks post-dosing. In this study, the...

ClinicalTrials.gov 2025-05-13 Icahn School of Medicine at Mount Sinai

ClinicalTrials.gov CLINICAL TRIAL psilocybin DepressionMechanism of ActionReceptor Pharmacology Other Major Depressive DisorderPsilocybin

A Phase 2a, Placebo-Controlled Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder

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...

ClinicalTrials.gov 2025-05-12 Queen's University

ClinicalTrials.gov CLINICAL TRIAL psilocybin AnxietyBrain ImagingClinical TrialHealthcare WorkersSafety Clinical Trial Generalized Anxiety Disorder (GAD)Psilocybin (drug)

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Source	Count	Share	Status
Europe PMC	2,554	64.3%	Active
PubMed	302	7.6%	Active
ClinicalTrials.gov	287	7.2%	Active
OpenAlex	283	7.1%	Active
PsyArXiv	216	5.4%	Active
Crossref	157	3.9%	Active
bioRxiv	142	3.6%	Active

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