Which psilocybin trials are recruiting

Eligibility summary: Ages 21 and up · all sexes · healthy volunteers accepted

This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. Four sites with experience in conducting psilocybin research will be involved in this trial: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), and New York University (NYU). The proposed study will treat 66 participants (22 at each site), randomized to receive either: 1) oral psilocybin (30 mg in session 1 and either 30 mg or 40 mg in session 2); or 2) oral niacin (150 mg in session 1 and either 150 mg or 200 mg in session 2), with sessions 1 week apart.

sponsor

Johns Hopkins University

site

• University of Alabama at Birmingham, Birmingham

started

Nov 2023

updated

Jun 2026

phase

Phase 2

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

site

• UAB Psychiatry and Behavioral Neurology, Birmingham

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 75 · all sexes · patients only

The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.

sponsor

VA Office of Research and Development

sites

• Birmingham VA Medical Center, Birmingham, AL
• Tuscaloosa VA Medical Center, Tuscaloosa, AL

started

Aug 2026

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 25 to 65 · female only · patients only

The primary purpose of this study is to preliminarily estimate the efficacy of psilocybin-facilitated treatment for fibromyalgia. Investigators will assess the impact of psilocybin-facilitated treatment on pain, fatigue, and other fibromyalgia symptoms, in addition to the level of functioning and quality of life. Investigators will also evaluate potential mediators of treatment (e.g., treatment expectations, pain characteristics, personality, beliefs/cognitions, emotions). Investigators hypothesize psilocybin treatment will significantly reduce symptom severity in fibromyalgia patients.

sponsor

University of Alabama at Birmingham

site

• UAB Beacon Tower, Birmingham

started

Nov 2023

updated

Mar 2026

phase

Early phase 1

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

site

• Lighthouse Psychiatry, Gilbert

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 and up · all sexes · patients only

The study tries to improve our treatments for people who have obsessive-compulsive disorder (OCD) by testing psilocybin, a mind altering drug that changes activity in brain areas involved in OCD. 30 patients with moderate or more severe OCD who are not taking mind altering medications or street drugs will participate in a 12 week study. Participants will be assigned (by luck of the draw) to take a low, medium, or high dose whole psilocybin mushroom contained in three chocolate pieces, prepared for this study by the Scottsdale Research Institute.

sponsor

Francisco A Moreno

site

• The Clinical and Translational Sciences Research Center, Tucson

started

May 2026

updated

Jul 2026

phase

Phase 1

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

site

• Pillar Clinical Research - Little Rock

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

sites

• Behavioral Research Specialists, LLC, Glendale
• CalNeuro Research Group, Los Angeles
• ATP Clinical Research, Orange
• NRC Research Institute, Orange
• Psychedelic Science Institute, Santa Monica
• Inland Psychiatric Medical Group Inc (IPMG Research), San Juan Capistrano
• Sun Valley Research Center, Imperial
• Stanford University, Stanford

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 50 to 85 · all sexes · healthy volunteers accepted

This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being. The main questions it aims to answer are, does psilocybin: 1. Acutely increase complexity of EEG activity in older adults with low well-being, as modulated by the presence of biomarkers of Alzheimer's disease (AD) pathology. 2. Longitudinally decrease plasma markers of neuroinflammation, as modulated by the presence of biomarkers of AD pathology. 3. Explore longitudinal changes in autonomic physiology via wearable recording devices as well as longitudinal structural and functional brain changes measured in the MRI Participants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits. Most visits will be between 1 to 3 hours, but the dosing visit will last a minimum of 8 hours and could be as long as 12 hours. During the dosing visit, all participants will receive a single dose of the study drugs and dosages listed below. Researchers will compare participants who receive the following drug options: * A low-to-moderate dose of Psilocybin (5-10 mg) * A moderate-to-high dose of Psilocybin (25-30 mg) * A low-to-moderate dose of Dextromethorphan (30-60 mg) * A moderate-to-high dose of Dextromethorphan (80-90 mg)

sponsor

Jennifer Mitchell

site

• University of California San Francisco, Sandler Neuroscience Building, San Francisco

started

Jun 2026

updated

Jun 2026

phase

Phase 1

Eligibility summary: Ages 21 to 70 · all sexes · healthy volunteers accepted

One hundred twenty healthy participants, ages 21 to 70, who experience moderate-to-lower-than-average mental well-being will be evenly randomized into four different study arms, using a 2x2 factorial design. Depending on the study arm, participants will either receive an inactive placebo or up to 25mg psilocybin (oral dose), in one of two set and setting conditions; drug administration contexts that are predicted to modulate drug effects. The purpose of this study is to evaluate any interaction effects between an oral dose of psilocybin and the surrounding context (set and setting).

sponsor

Robin Carhart-Harris, PhD, MA

site

• UCSF Mission Bay, San Francisco

started

Oct 2024

updated

Jun 2026

phase

Phase 2

Eligibility summary: Ages 21 and up · all sexes · healthy volunteers accepted

The long-term objective of this project is to characterize how psilocybin affects visual perception and the brain's representation of the visual environment. It is known that psilocybin alters aspects of visual perception, but the underlying brain mechanisms contributing to these effects are poorly understood. The proposed work will address these questions in a large, diverse sample of healthy human subjects by using functional magnetic resonance imaging (fMRI) to measure the brain's responses to visual stimuli. The proposed research will document which brain areas mediate the effects of psilocybin. The technique of fMRI will be employed to measure brain activity in different brain areas while subjects are performing a visual perceptual task.

sponsor

University of California, Berkeley

site

• University of California, Berkeley

started

Mar 2024

updated

Jul 2026

phase

Phase 1

Eligibility summary: Ages 60 to 85 · all sexes · healthy volunteers accepted

Participants in this study will undergo a series of non-invasive tests and activities designed to understand how a single dose of psilocybin might influence cognition and emotional well-being in healthy older adults. After providing written informed consent, eligible participants, aged between 60 and 85, will be randomly assigned to receive a dose of psilocybin ranging from a microdose to a moderate-to-high dose. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity.

sponsor

University of California, Berkeley

site

• University of California, Berkeley

started

Nov 2025

updated

Oct 2025

phase

Phase 1

Eligibility summary: Ages 25 and up · all sexes · healthy volunteers accepted

The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is "Does mindfulness training enhance the effects of psychedelic therapy (psilocybin) on mental health?" Interested individuals will complete an initial eligibility session and eligible participants will then be randomized into one of two groups: one dose of psilocybin (administered under the supervision of study therapists) combined with 8 weeks of weekly mindfulness training classes (Arm 1) or psilocybin alone (Arm 2). Both groups will complete baseline and post-treatment assessment sessions where they will complete questionnaires, computerized cognitive tests, and have an EEG (a measure of electrical activity in the brain) and functional MRI of brain if possible. Both groups will also complete 2 follow-up surveys (at \~8 weeks, and 1 year after the post-treatment assessment) either online through REDCap or by phone or video call with a research assistant.

sponsor

University of Southern California

site

• Univeristy of Southern California Brain and Creativity Institute, Los Angeles

started

Jul 2025

updated

Aug 2026

phase

Phase 2

Eligibility summary: Ages 18 and up · all sexes · patients only

This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).

sponsor

Charles S. Grob, M.D.

sites

• Marin Cancer Care, Greenbrae
• University of California, Los Angeles
• University of San Francisco, San Francisco
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

started

Jan 2025

updated

Nov 2025

phase

Phase 2

Eligibility summary: Ages 40 to 80 · all sexes · patients only

The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.

sponsor

Joshua Woolley, MD, PhD

site

• University of California, San Francisco

started

Aug 2024

updated

Aug 2026

phase

Phase 2

Eligibility summary: Ages 21 to 70 · all sexes · patients only

Through an open-label study involving a small group of UCSD physicians experiencing burnout, the investigators will evaluate the feasibility, safety, and preliminary effectiveness of PAT to reduce burnout symptoms.

sponsor

University of California, San Diego

site

• UC San Diego, San Diego

started

Jan 2025

updated

Jul 2026

phase

Phase 1 / Phase 2

Eligibility summary: Ages 21 to 60 · all sexes · patients only

The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder. This study is a randomized, two-arm, fixed dose trial that will test the feasibility, acceptability, and participant and therapist adherence to PA-CBT. Both treatment arms will receive two doses of psilocybin (10mg and then 25mg, separated by one month). In Phase II, participants will be randomized (1:1) to either a 12-session PA-CBT or a 6-session standard psilocybin-assisted therapy (PAT) condition (3 hours of preparation plus 3 hours of supportive therapy integration following the psilocybin experiences).

sponsor

University of California, Los Angeles

site

• UCLA Semel Institute, Los Angeles

started

Jan 2026

updated

Feb 2026

phase

Phase 1 / Phase 2

Eligibility summary: Ages 65 to 85 · all sexes · healthy volunteers accepted

This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

sponsor

University of Colorado, Denver

site

• University of California San Francisco (UCSF) Department of Neurology, San Francisco

started

Apr 2026

updated

Aug 2026

phase

Phase 1

Eligibility summary: Ages 18 to 25 · all sexes · patients only

This is a single site trial of psilocybin therapy for the treatment of refractory Anorexia Nervosa in young adults. The psilocybin therapy will include three preparatory sessions, psilocybin dosing session one (20mg), two integration sessions, psilocybin dosing session two (up to 25mg), and three final integration sessions. Eating disorder symptoms will be measured pre and post treatment. One to two family member(s) of each young adult participant will be enrolled in the study. One of which will be required to attend a portion of two preparatory sessions and a portion of two integration sessions and receive psychoeducation about supporting the young adult participant through preparation and integration for psilocybin therapy. Investigators hypothesize that psilocybin will increase cognitive flexibility and that this increase will predict long-term changes in cognitive rigidity, habitual eating, and exercise behaviors in patients with Anorexia Nervosa.

sponsor

Marissa Raymond-Flesch, MD, MPH

site

• University of California, San Francisco

started

Nov 2024

updated

Mar 2026

phase

Phase 2

Eligibility summary: Ages 18 to 70 · all sexes · patients only

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 addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.

sponsor

Charles Raison

site

• Vail Health Behavioral Health, Edwards

started

May 2025

updated

Aug 2026

phase

Phase 2

Eligibility summary: Ages 21 to 100 · all sexes · patients only

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 brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.

sponsor

NYU Langone Health

site

• University of Colorado Anschutz Medical campus (CU AMC), Aurora

started

May 2023

updated

Dec 2025

phase

Phase 2 / Phase 3

Eligibility summary: Ages 65 to 85 · all sexes · healthy volunteers accepted

This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

sponsor

University of Colorado, Denver

site

• University of Colorado Anschutz Medical Campus, Aurora

started

Apr 2026

updated

Aug 2026

phase

Phase 1

Eligibility summary: Ages 21 and up · female only · patients only

The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.

sponsor

University of Colorado, Denver

sites

• Outpatient CTRC, Aurora
• University of Colorado Cancer Center, Aurora

started

Nov 2024

updated

Apr 2026

phase

Phase 1

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

site

• Yale School of Medicine - Yale Program for Psychedelic Science, New Haven

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 25 to 55 · all sexes · patients only

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.

sponsor

Yale University

site

• Yale University, New Haven

started

May 2025

updated

Jul 2026

phase

Phase 1

Eligibility summary: Ages 21 to 70 · all sexes · healthy volunteers accepted

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 inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.

sponsor

Yale University

site

• VA Connecticut Healthcare System, West Haven

started

May 2025

updated

Jul 2026

phase

Early phase 1

Eligibility summary: Ages 18 and up · all sexes · healthy volunteers accepted

The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.

sponsor

Yale University

site

• Connecticut Mental Health Center - Yale School of Medicine, New Haven

started

Oct 2024

updated

Mar 2026

phase

Phase 1

Eligibility summary: Ages 21 to 65 · all sexes · patients only

The purpose of this study is to understand whether psilocybin therapy is safe and well tolerated in improving chronic pain and increasing motivation to quit smoking for people who have chronic pain and smoke cigarettes. Psilocybin is a psychedelic drug and the active ingredient in "magic mushrooms." Psilocybin is currently being studied in clinical trials but has no current medical use in the United States. Some studies have shown that a dose of psilocybin can help people quit smoking. Other studies have shown that a dose of psilocybin may improve certain chronic pain conditions, such as migraine headaches. We believe that it may also be helpful for people who smoke and have chronic pain, but this has not been tested yet.

sponsor

Yale University

site

• Department of Veterans Affairs, West Haven

started

Jul 2026

updated

Aug 2026

phase

Early phase 1

Eligibility summary: Ages 40 to 80 · all sexes · patients only

The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.

sponsor

Yale University

site

• Yale University, New Haven

started

Jul 2026

updated

Jul 2026

phase

Phase 2

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

sites

• CNS Healthcare, Jacksonville
• Accel Research Sites - Maitland
• Aqualane Clinical Research, Naples

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

sites

• Psych Atlanta, Marietta
• Emory University Dept of Psychiatry and Behavioral Studies, Atlanta

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 65 to 85 · all sexes · healthy volunteers accepted

This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

sponsor

University of Colorado, Denver

site

• Emory University Brain Health Center, Atlanta

started

Apr 2026

updated

Aug 2026

phase

Phase 1

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

site

• Rush University, Chicago

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 21 to 65 · all sexes · patients only

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 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of ketamine.

sponsor

University of Iowa

site

• University of Iowa Health Care, Iowa City

started

Jun 2025

updated

Nov 2025

phase

Phase 2

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

sites

• Atlas Psychiatry, New Orleans
• Tandem Clinical Research, Marrero

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 25 to 65 · all sexes · patients only

The primary purpose of this study is to preliminarily determine if the use of psilocybin to promote abstinence from methamphetamine is feasible and well tolerated in populations such as those found in Northern Louisiana. Investigators will assess the impact of psilocybin-facilitated treatment on methamphetamine abstinence, craving, negative affect, cognitive function and quality of life. Components of the psilocybin experience will also be measured (persisting effects, quality of life, challenging experiences, etc). Investigators will assess feasibility and tolerability as rates of retention and challenging experiences, among other factors.

sponsor

Kevin Murnane

site

• LSU Health Shreveport, Shreveport

started

Apr 2025

updated

Oct 2025

phase

Early phase 1

Eligibility summary: Ages 21 and up · all sexes · healthy volunteers accepted

This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. Four sites with experience in conducting psilocybin research will be involved in this trial: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), and New York University (NYU). The proposed study will treat 66 participants (22 at each site), randomized to receive either: 1) oral psilocybin (30 mg in session 1 and either 30 mg or 40 mg in session 2); or 2) oral niacin (150 mg in session 1 and either 150 mg or 200 mg in session 2), with sessions 1 week apart.

sponsor

Johns Hopkins University

site

• Johns Hopkins University School of Medicine, Baltimore

started

Nov 2023

updated

Jun 2026

phase

Phase 2

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

site

• Johns Hopkins Medicine, Baltimore

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 and up · all sexes · patients only

This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population.

sponsor

Johns Hopkins University

site

• Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore

started

Apr 2025

updated

Aug 2026

phase

Early phase 1

Eligibility summary: Ages 18 to 75 · all sexes · healthy volunteers accepted

This research study will use computerized tasks, electroencephalography (EEG), and magnetic resonance imaging (MRI) to look at how the drug psilocybin, a naturally occurring compound contained in hundreds of species of psychoactive mushrooms, changes thoughts and brain activity.

sponsor

Johns Hopkins University

site

• Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore

started

Mar 2022

updated

Jul 2026

phase

Phase 1 / Phase 2

Eligibility summary: Ages 25 to 55 · all sexes · healthy volunteers accepted

The aim of this double-blind, placebo-controlled, within-subjects study is to determine whether other psychoactive substances can produce experiences akin to those seen with classic psychedelics. Screening involves a medical and psychiatric examination, including blood draw, history and physical, interviews, and questionnaires. Eligible participants will then be asked to complete up to 6 experimental drug administration session during which the participants will potentially receive and report on the subjective effects of 6 different psychoactive substances or inactive placebo. Drug assignment for some sessions will be randomized (like flipping a count or rolling a pair of dice), and both participants and study staff will be blind to the drug condition on any given day. Participants will also complete 2 preparation sessions (4 hours total) before the first experimental session, and follow-up visits after each session to discuss and debrief on the participants subjective experience.

sponsor

Johns Hopkins University

site

• Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore

started

Feb 2025

updated

Feb 2026

phase

Phase 1

Eligibility summary: Ages 21 to 70 · all sexes · patients only

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 psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with outpatient buprenorphine maintenance, quality of life, and mood.

sponsor

Johns Hopkins University

site

• Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore

started

Feb 2024

updated

Jul 2026

phase

Phase 2

Eligibility summary: Ages 18 and up · all sexes · patients only

This multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).

sponsor

Charles S. Grob, M.D.

site

• Sunstone Therapies, Rockville

started

Jan 2025

updated

Nov 2025

phase

Phase 2

Eligibility summary: Ages 21 to 60 · all sexes · healthy volunteers accepted

The purpose of this study is to assess the effects of 5-HT1A receptor blockade on the acute subjective effects of psilocybin, as measured through subjective survey measures and acute electroencephalography (EEG). Further, the investigators will assess the effects of psilocybin on post-acute sleep and dreaming through the use of sleep EEG and sleep and dream diaries.

sponsor

Johns Hopkins University

site

• Center for Psychedelics and Consciousness Research, Baltimore

started

Aug 2026

updated

Aug 2026

phase

Early phase 1

Eligibility summary: Ages 21 and up · all sexes · patients only

The purpose of this study is to assess the safety and effectiveness of co-administered MDMA and psilocybin in military Veterans with a diagnosis of Posttraumatic Stress Disorder (PTSD). To apply or learn more, please view our website: https://hopkinspsychedelic.org/pamvet

sponsor

Johns Hopkins University

site

• Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore

started

Sep 2025

updated

Oct 2025

phase

Phase 1

Eligibility summary: Ages 21 to 65 · all sexes · healthy volunteers accepted

Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration. The purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic/pharmacodynamic modeling.

sponsor

Johns Hopkins University

site

• Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore

started

Jul 2026

updated

Jul 2026

phase

Phase 1 / Phase 2

Eligibility summary: Ages 18 to 85 · all sexes · patients only

This open-label pilot study examines whether the hallucinogenic drug, psilocybin, given under supportive conditions, is safe and effective for depression in people with Mild Cognitive Impairment (MCI) or early Alzheimer's Disease (AD). This study will also assess whether psilocybin may improve quality of life in those individuals.

sponsor

Johns Hopkins University

site

• Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore

started

Mar 2021

updated

Mar 2026

phase

Early phase 1

Eligibility summary: Ages 21 to 80 · all sexes · patients only

This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D). Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects.

sponsor

Johns Hopkins University

site

• Johns Hopkins University School of Medicine, Baltimore

started

Apr 2024

updated

Jul 2026

phase

Phase 1

Eligibility summary: Ages 18 and up · female only · patients only

A Phase 2, Open-Label Study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Posttraumatic Stress Disorder (PTSD).

sponsor

Sunstone Medical

site

• Sunstone Medical, PC, Rockville

started

May 2026

updated

Jul 2026

phase

Phase 2

Eligibility summary: Ages 18 and up · all sexes · patients only

This pilot study will evaluate the therapeutic potential of psilocybin in people with Cannabis Use Disorder (CUD). This study will examine the impact of psilocybin treatment on cannabis use and related variables in 12 people with CUD. This is an open-label proof-of-concept trial in which participants will complete a 12-week course of study treatment including two psilocybin sessions with psychological support, and follow-up assessments 3 and 6 months after the first psilocybin session.

sponsor

Johns Hopkins University

site

• Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore

started

Nov 2024

updated

Mar 2026

phase

Phase 1

Eligibility summary: Ages 18 and up · all sexes · patients only

The main purpose of the current studies is to evaluate the safety and tolerability of psilocybin in patients with chronic stroke.

sponsor

Johns Hopkins University

site

• Johns Hopkins, Baltimore

started

Feb 2026

updated

Feb 2026

phase

Phase 1

Eligibility summary: Ages 18 and up · all sexes · patients only

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)

sponsor

Yvan Beaussant, MD, MSci

site

• Dana-Farber Cancer Institute, Boston

started

Sep 2024

updated

Aug 2026

phase

Phase 2

Eligibility summary: Ages 65 to 85 · all sexes · healthy volunteers accepted

This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

sponsor

University of Colorado, Denver

site

• Dana-Farber Cancer Institute, Boston

started

Apr 2026

updated

Aug 2026

phase

Phase 1

Eligibility summary: Ages 18 to 55 · all sexes · patients only

This open-label functional Magnetic Resonance Imaging (fMRI) study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with major depressive disorder.

sponsor

Sharmin Ghaznavi

site

• Athinoula A. Martinos Center for Biomedical Imaging, Charlestown

started

Sep 2024

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

site

• Institute for Integrative Therapies, Eden Prairie

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 65 to 85 · all sexes · healthy volunteers accepted

This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

sponsor

University of Colorado, Denver

site

• University of Nebraska Medical Center, Omaha

started

Apr 2026

updated

Aug 2026

phase

Phase 1

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

site

• Bio Behavioral Health, Toms River

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 89 · all sexes · patients only

This study is a community-informed, pragmatic, open-label, phase 1 clinical trial of group-format psilocybin-assisted therapy (GPAT) for individuals with post-traumatic stress disorder (PTSD). The primary objectives of this phase 1 study are to assess the safety and feasibility of (GPAT) for individuals with (PTSD) and to evaluate preliminary effects on PTSD severity.

sponsor

University of New Mexico

site

• Interdisciplinary Substance Use and Brain Injury (ISUBI), Albuquerque

started

May 2026

updated

May 2026

phase

Phase 1

Eligibility summary: Ages 18 to 65 · all sexes · patients only

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 consented to yield 240 randomized participants. This study is part of the NIH HEAL Initiative (https://heal.nih.gov/). In Stage 1, subjects will be randomly assigned to one of three groups: psilocybin 30 mg (high dose), psilocybin 20 mg (medium dose), and psilocybin 1 mg (control condition). By the end of Stage 1, an interim statistical analysis will be performed. The study will proceed to Stage 2 if at least one of the active dosages of psilocybin demonstrates 1) acceptable safety, based on analysis of safety data from Stage 1; and 2) conditional power of at least 25%, based on effect size estimates for the primary opioid use outcome (weeks of biologically-verified abstinence during 24 weeks of follow-up). Using a priori decision rules, the interim analysis will determine which of the active treatment groups (30 mg, 20 mg, or both) will be retained in Stage 2 of the trial. Stage 2 will continue the study, using the same treatment and assessment protocols, but retaining only the active dosage or dosages with a high probability of demonstrating efficacy relative to the psilocybin 1 mg control condition. The primary aims are to 1) Evaluate safety and efficacy outcomes in Stage 1 subjects in order to optimize design of the Stage 2, 2) Determine whether treatment with a single high (30 mg) or medium (20 mg) dose of psilocybin improves OUD treatment outcomes, relative to psilocybin 1 mg (control condition), in patients who continue to use illicit opioids despite adherence to methadone treatment, 3) Evaluate the effects of high-dose psilocybin and medium dose psilocybin on self-reported OUD-related neuropsychopathology, and 4) Identify likely responders to psilocybin treatment by using machine learning to model post-treatment OUD outcomes, based on pretreatment characteristics including all relevant clinical data, evaluations, and questionnaires.

sponsor

NYU Langone Health

sites

• Duke City Recovery Toolbox, Albuquerque
• University of New Mexico, Albuquerque

started

Dec 2025

updated

Jan 2026

phase

Phase 2

Eligibility summary: Ages 21 and up · all sexes · healthy volunteers accepted

This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. Four sites with experience in conducting psilocybin research will be involved in this trial: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), and New York University (NYU). The proposed study will treat 66 participants (22 at each site), randomized to receive either: 1) oral psilocybin (30 mg in session 1 and either 30 mg or 40 mg in session 2); or 2) oral niacin (150 mg in session 1 and either 150 mg or 200 mg in session 2), with sessions 1 week apart.

sponsor

Johns Hopkins University

site

• New York University, New York

started

Nov 2023

updated

Jun 2026

phase

Phase 2

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

site

• New York State Psychiatric Institute, New York

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 65 · all sexes · patients only

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 aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.

sponsor

NYU Langone Health

site

• NYU Langone Health, New York

started

Sep 2026

updated

Aug 2026

phase

Phase 2

Eligibility summary: Ages 18 to 65 · all sexes · patients only

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 consented to yield 240 randomized participants. This study is part of the NIH HEAL Initiative (https://heal.nih.gov/). In Stage 1, subjects will be randomly assigned to one of three groups: psilocybin 30 mg (high dose), psilocybin 20 mg (medium dose), and psilocybin 1 mg (control condition). By the end of Stage 1, an interim statistical analysis will be performed. The study will proceed to Stage 2 if at least one of the active dosages of psilocybin demonstrates 1) acceptable safety, based on analysis of safety data from Stage 1; and 2) conditional power of at least 25%, based on effect size estimates for the primary opioid use outcome (weeks of biologically-verified abstinence during 24 weeks of follow-up). Using a priori decision rules, the interim analysis will determine which of the active treatment groups (30 mg, 20 mg, or both) will be retained in Stage 2 of the trial. Stage 2 will continue the study, using the same treatment and assessment protocols, but retaining only the active dosage or dosages with a high probability of demonstrating efficacy relative to the psilocybin 1 mg control condition. The primary aims are to 1) Evaluate safety and efficacy outcomes in Stage 1 subjects in order to optimize design of the Stage 2, 2) Determine whether treatment with a single high (30 mg) or medium (20 mg) dose of psilocybin improves OUD treatment outcomes, relative to psilocybin 1 mg (control condition), in patients who continue to use illicit opioids despite adherence to methadone treatment, 3) Evaluate the effects of high-dose psilocybin and medium dose psilocybin on self-reported OUD-related neuropsychopathology, and 4) Identify likely responders to psilocybin treatment by using machine learning to model post-treatment OUD outcomes, based on pretreatment characteristics including all relevant clinical data, evaluations, and questionnaires.

sponsor

NYU Langone Health

sites

• StartCare, Brooklyn
• NYU Langone Health, New York
• VIP Community Services, Inc, The Bronx

started

Dec 2025

updated

Jan 2026

phase

Phase 2

Eligibility summary: Ages 21 to 100 · all sexes · patients only

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 brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.

sponsor

NYU Langone Health

site

• NYU Langone Health, New York

started

May 2023

updated

Dec 2025

phase

Phase 2 / Phase 3

Eligibility summary: Ages 22 and up · all sexes · patients only

The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg). The main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses. Participants will: * Agree to be enrolled in the study for up to 13 months. * Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy. * Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits. * Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.

sponsor

James J. Peters Veterans Affairs Medical Center

site

• James J. Peters Department of Veterans Affairs Medical Center, The Bronx

started

Aug 2026

updated

Aug 2026

phase

Phase 1 / Phase 2

Eligibility summary: Ages 21 to 80 · all sexes · patients only

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.

sponsor

Icahn School of Medicine at Mount Sinai

site

• Icahn School of Medicine at Mount Sinai, Center for Psychedelic Therapy Research, New York

started

Feb 2025

updated

May 2025

phase

Phase 2

Eligibility summary: Ages 18 and up · all sexes · patients only

This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.

sponsor

Rachel Yehuda

site

• The Parsons Research Center for Psychedelic Healing, New York

started

Aug 2026

updated

Aug 2026

phase

Phase 2

Eligibility summary: Ages 18 and up · all sexes · patients only

The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.

sponsor

COMPASS Pathways

site

• NY, New York

started

Sep 2026

updated

Aug 2026

phase

Phase 2 / Phase 3

Eligibility summary: Ages 65 to 85 · all sexes · healthy volunteers accepted

This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

sponsor

University of Colorado, Denver

site

• New York University Langone Health, Center for Psychedelic Medicine, New York

started

Apr 2026

updated

Aug 2026

phase

Phase 1

Eligibility summary: Ages 21 to 65 · all sexes · patients only

The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard "psychological support" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).

sponsor

Anthony P King

site

• The Ohio State University Medical Center, Columbus

started

Jul 2026

updated

Jun 2026

phase

Phase 2

Eligibility summary: Ages 18 and up · all sexes · patients only

This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings of existential distress (i.e., loss of meaning, demoralization, despair). Among all cancer patients, those diagnosed with lung cancer have the highest prevalence of mood disorders, such as depression (up to 40%) leading to profound deterioration in quality of life, prolonged hospital stays, poorer treatment adherence, decreased survival rates, and high rates of suicide (5- and 3-times higher than the general population and other cancer patients, respectively). Psilocybin is substance being studied in the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung cancer.

sponsor

Alan Davis

site

• Ohio State University Comprehensive Cancer Center, Columbus

started

Jan 2026

updated

May 2026

phase

Phase 2

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

site

• SP Research PLLC, Oklahoma City

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 75 · all sexes · patients only

The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.

sponsor

VA Office of Research and Development

site

• VA Portland Health Care System, Portland, OR

started

Aug 2026

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

sites

• Adams Clinical Philadelphia, Philadelphia
• Flourish Research Philadelphia, Philadelphia

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 75 · all sexes · patients only

The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.

sponsor

VA Office of Research and Development

site

• Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

started

Aug 2026

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 60 · all sexes · patients only

The goal of this study is to test addiction-related brain circuitry (motivation/reward and inhibition) as well as neurocognitive circuitry prior to and following low or high dose psilocybin (PEX010 from Filament). Using fMRI, brain circuits will be examined that are relevant to drug relapse as well as neurocognitive flexibility circuits in individuals with opioid use disorder. Investigators will randomize 24 males and females, aged 18 - 60, in the greater Philadelphia area, to either 1mg or 25 mg of psilocybin. Participants will come to our offices for screening visits - these are assessments, interviews, and some medical tests (such as a history and physical, as well as a fasting blood draw) to help determine eligibility for our study. If eligible, participants will be brought to research offices at 3535 Market Street in Philadelphia for about 7 visits. These visits include pre-dose psilocybin preparation therapy, baseline assessments and neuropsychological testing, psilocybin dosing, post dose therapy visits, and post dose assessments.

sponsor

University of Pennsylvania

site

• University of Pennsylvania, Philadelphia

started

Dec 2025

updated

Jul 2026

phase

Phase 2

Eligibility summary: Ages 18 to 60 · all sexes · patients only

Investigators will recruit 36 individuals on MAT for OUD for a double-blind, placebo-controlled design to determine whether PEX010 (25-mg/d) shows preliminary efficacy on neural correlates of neurocognition and on clinical outcomes. Participants will be randomized to either (single dose) 25-mg (PEX010-25 group) or 1-mg (PPEX010-1 group) PEX010 in a 2:1 ratio. Brain and behavioral testing sessions will precede Psilocybin (PSI) dosing day by 24-48 hours and will follow PSI dosing by 1 week. After an initial 6 phases, participants will come into the lab to submit a urine screen 2x/week and to complete a short survey in order to collect data on drug use, MAT adherence, and mental health symptoms. The investigators hypothesize the PEX010-25 (vs. PEX010-1) group will have better clinical outcomes (e.g., lower average percent positive urine drug screens, more late relapses, higher MAT adherence). There are research follow ups every three months out to one year post dose.

sponsor

Anna Rose Childress, Ph.D.

site

• University of Pennsylvania, Philadelphia

started

Oct 2025

updated

Oct 2025

phase

Phase 2

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

sites

• Brain Health Consultants and TMS Center, Houston
• Flourish Research San Antonio, San Antonio
• Austin Clinical Trial Partners, Austin
• North Texas Clinical Trials, Fort Worth

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 25 to 70 · all sexes · patients only

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.

sponsor

The University of Texas Health Science Center, Houston

site

• The University of Texas Health Science Center at Houston, Houston

started

Jul 2025

updated

Aug 2026

phase

Phase 2

Eligibility summary: Ages 22 to 65 · all sexes · patients only

The purpose of this study is to determine the safety and feasibility of sequencing psilocybin therapy with a short-duration, aiTBS protocol (Stanford Accelerated Intelligent Neuromodulation Therapy, or SAINT) in individuals with treatment-resistant major depressive disorder.

sponsor

University of Texas at Austin

site

• Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600, Austin

started

Jan 2025

updated

Nov 2025

phase

Phase 2

Eligibility summary: Ages 25 and up · all sexes · patients only

To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.

sponsor

M.D. Anderson Cancer Center

site

• MD Anderson Cancer Center, Houston

started

Apr 2024

updated

Aug 2026

phase

Phase 2

Eligibility summary: Ages 21 to 64 · all sexes · patients only

The principal investigator for this study plans to build upon the psilocybin-assisted therapy intervention used in prior completed trials to conduct an open-label trial of two psilocybin administration sessions combined with psychotherapy to investigate the safety, tolerability, and clinical efficacy of psilocybin-assisted therapy for the treatment of PTSD in US Veterans.

sponsor

Baylor College of Medicine

site

• Baylor College of Medicine, Houston

started

Jan 2025

updated

Jan 2026

phase

Phase 2

Eligibility summary: Ages 18 and up · all sexes · patients only

This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.

sponsor

M.D. Anderson Cancer Center

site

• The University of Texas M. D. Anderson Cancer Center, Houston

started

May 2025

updated

Aug 2026

phase

Phase 2

Eligibility summary: Ages 18 to 65 · all sexes · healthy volunteers accepted

The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD).

sponsor

University of Virginia

site

• University of Virginia, Charlottesville

started

Mar 2026

updated

Jun 2026

phase

Early phase 1

Eligibility summary: Ages 18 to 85 · all sexes · patients only

The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

sponsor

Cybin IRL Limited

sites

• Seattle Neuropsychiatric Treatment Center, Seattle
• Core Clinical Research, Everett

started

Dec 2025

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 18 to 75 · all sexes · patients only

The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.

sponsor

VA Office of Research and Development

site

• VA Puget Sound Health Care System Seattle Division, Seattle, WA

started

Aug 2026

updated

Aug 2026

phase

Phase 3

Eligibility summary: Ages 21 to 65 · all sexes · patients only

Primary Aim: In participants with OUD, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone formulation. Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a buprenorphine-naloxone maintenance therapy. Secondary Aim: To evaluate the effect of concurrent buprenorphine-naloxone use on the effects of psilocybin therapy. Descriptive Aim: To describe any changes in self-efficacy, quality of life, pain.

sponsor

University of Wisconsin, Madison

site

• University of Wisconsin, Madison

started

Jan 2021

updated

Jul 2026

phase

Phase 1

Eligibility summary: Ages 18 to 70 · all sexes · healthy volunteers accepted

This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gained during the psychedelic experience to remain vivid after they will have faded in subjects who receive psilocybin followed by sham taVNS or no VNS.

sponsor

University of Wisconsin, Madison

site

• University of Wisconsin - Madison

started

Jan 2025

updated

Jul 2026

phase

Phase 1

Eligibility summary: Ages 18 to 65 · all sexes · healthy volunteers accepted

The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing. Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing. Participants will: * Receive one of four possible combinations of medications * Undergo an MRI * Complete questionnaires * Undergo transcranial magnetic stimulation (TMS) and EEG

sponsor

University of Wisconsin, Madison

site

• UW School of Medicine and Public Health, Madison

started

Aug 2025

updated

Aug 2026

phase

Phase 1