Active Psilocybin Clinical Trials

Active Psilocybin Clinical Trials: 2025–2026 Tracker

Clinical trials are the fastest-moving part of the psilocybin research landscape. New trials open regularly, existing trials announce results, and the FDA's Breakthrough Therapy designation for psilocybin-assisted therapy in treatment-resistant depression (TRD) and major depressive disorder (MDD) has accelerated the entire pipeline.

This page tracks active and recently completed trials, their enrollment status, and how to find out if you qualify. Trials are updated as new information becomes available; check ClinicalTrials.gov for the most current enrollment status.

How to Read This Page

Phase I — Safety, dosing, and pharmacokinetics in small healthy volunteer groups Phase II — Efficacy signals and dose optimization in target population; usually 50–200 participants Phase III — Confirmatory efficacy and safety in larger populations (200–1,000+); required for FDA approval

Primary investigator — The lead researcher or institution running the trial Enrollment status — Active/Recruiting means you may qualify now

Major Active Trials (2025–2026)

Treatment-Resistant Depression (TRD)

COMPASS Pathways — COMP360 Phase IIb/III

• Drug: COMP360 (synthetic psilocybin, 25mg dose)
• Condition: Treatment-resistant depression
• Status: Phase 3 initiated; multiple international sites
• Sites: 100+ sites across the US, Europe, and Canada
• Notable: Largest psilocybin trial ever conducted; results will determine FDA NDA submission timeline
• Find out more: ClinicalTrials.gov identifier NCT04077866

Usona Institute — PSIL201

• Drug: Psilocybin (25mg)
• Condition: Major depressive disorder (MDD)
• Status: Phase 2 completed; Phase 3 in preparation
• Notable: FDA Breakthrough Therapy designation granted 2022; enrollment at 80+ sites
• Find out more: ClinicalTrials.gov identifier NCT04383795

Johns Hopkins — Multiple Active Trials

• Psilocybin for major depression with concurrent SSRI discontinuation support
• Psilocybin for anorexia nervosa (Phase 2)
• Psilocybin for chronic Lyme disease-associated mood disorders
• Contact: hopkinspsychedelic.org for current enrollment

NYU Grossman School of Medicine

• Psilocybin for alcohol use disorder (Phase 2 completed — positive results)
• Psilocybin for major depression in cancer patients (ongoing)
• Contact: psychedelic.med.nyu.edu

PTSD and Trauma

MAPS — Psilocybin for PTSD (Exploratory)

• MAPS is primarily known for MDMA-assisted therapy (which received expanded access authorization), but is running early psilocybin PTSD trials
• Phase 2; contact MAPS.org for trial participation information

Veterans Psilocybin Research Initiative

• Multiple VA-adjacent trials examining psilocybin for combat-related PTSD
• Nonprofit-funded given VA funding restrictions on Schedule I research
• Notable sites: UC San Diego, Massachusetts General Hospital
• See the Veterans Resource Page for specific contacts

Addiction and Substance Use

University of Wisconsin — Tobacco Cessation

• Building on the landmark Johns Hopkins tobacco cessation pilot (2014)
• 80% abstinence rate at 6 months in the original pilot — among the highest reported for any smoking intervention
• Phase 2 randomized controlled trial now enrolling
• ClinicalTrials.gov identifier NCT04052555

NYU — Alcohol Use Disorder

• Phase 2 results published 2022: psilocybin produced significant reductions in heavy drinking versus active placebo
• Phase 3 in planning stage

University of Alabama — Cocaine Use Disorder

• Phase 1 safety trial completed; Phase 2 planning underway
• First rigorous psilocybin investigation for stimulant use disorders

Pain, Eating Disorders, OCD

Harvard Medical School / McLean Hospital — OCD

• Building on the only completed RCT for psilocybin in OCD (Moreno et al., 2006)
• Phase 2; enrollment ongoing
• All 9 participants in the original study showed symptom reduction — a remarkable result

University of California San Francisco (UCSF) — Anorexia Nervosa

• Phase 2; recruiting adults with established anorexia nervosa diagnosis
• Rationale: psilocybin's neuroplasticity and ego-softening effects may address the rigid self-perception patterns central to AN
• ClinicalTrials.gov: search UCSF + psilocybin + anorexia

Johns Hopkins — Headache Disorders

• Cluster headache (known colloquially as "suicide headache") anecdotally treated with psilocybin since the early 2000s
• Clusterbusters.org has patient reports dating to 2002
• Formal Phase 2 trial now underway at Johns Hopkins

Cancer and End-of-Life Care

Memorial Sloan Kettering + NYU Joint Trial

• Psilocybin for depression and anxiety in cancer patients
• Built on the landmark 2016 NYU (Griffiths) trial which showed 80% sustained improvement at 6 months
• Expanding patient population and refining dosing protocols

UCSF — Palliative Care

• Psilocybin for existential distress in terminal illness
• Emphasizes the "death acceptance" research strand pioneered by Roland Griffiths at Johns Hopkins

How to Qualify and Enroll

Step 1: Search ClinicalTrials.gov

1. Go to ClinicalTrials.gov
2. Search: "psilocybin" + your condition (e.g., "psilocybin depression")
3. Filter by Status: "Recruiting" and Country: "United States" (or your country)
4. Read the "Eligibility" section carefully before contacting

Step 2: Understand Eligibility

Most trials exclude participants who:

• Have personal or family history of psychosis or schizophrenia
• Are currently taking certain medications (particularly SSRIs, MAOIs, lithium)
• Have unstabilized cardiovascular conditions
• Have active suicidal ideation requiring immediate intervention
• Have first-degree relatives with schizophrenia or bipolar I

Most trials include participants who:

• Have a confirmed diagnosis of the target condition (e.g., TRD, MDD, AUD)
• Have tried and failed at least 2 prior treatments (for TRD-specific trials)
• Are medically stable
• Are willing to undergo pre-session preparation and post-session integration

Step 3: Contact the Site Coordinator

Each listed trial has a contact at the participating site. Reach out directly — you are not applying to Johns Hopkins or NYU, you are contacting the specific clinic running the trial in your city or region.

Trial participation is free. Participants typically receive compensation for time and travel.

Recent Results Worth Knowing (2024–2026)

COMPASS Phase 2b Results (2023): 25mg psilocybin showed significant antidepressant effects at 3 weeks in TRD. 29.1% of participants achieved remission — triple the rate of the 1mg control group. This result supports Phase 3 development.

NYU Alcohol Use Disorder (2022): Psilocybin-treated participants showed an 83% reduction in heavy drinking days at 8 months — a result that stunned addiction medicine researchers accustomed to modest outcomes.

Moffitt/UCSF Smoking Cessation (2022): 67% of participants remained abstinent at 12 months following psilocybin-assisted therapy, compared to 15–35% for best existing pharmacological approaches.

Hopkins Anorexia (2023): Small Phase 2a showing significant improvement in body image distortion and eating disorder symptoms at 3 months. Phase 2b now enrolling.

The FDA Timeline

Understanding where psilocybin-assisted therapy sits in the regulatory pipeline:

| Year | Event | |------|-------| | 2018 | FDA grants Breakthrough Therapy designation to COMPASS for psilocybin in TRD | | 2019 | FDA grants Breakthrough Therapy designation to Usona for psilocybin in MDD | | 2022–2023 | Major Phase 2 results published | | 2024 | FDA Advisory Committee review process begins | | 2025 | COMPASS and Usona anticipate NDA submissions | | 2026–2027 | Earliest potential FDA approval window |

If FDA approval comes, psilocybin-assisted therapy would move from Schedule I (no accepted medical use) to Schedule II or III, enabling legal prescribing nationwide — not just in Oregon and Colorado's state-level frameworks.

Accessing Psilocybin Outside of Trials

While trials represent the most scientifically rigorous path, legal options exist now:

• Oregon — Psilocybin service centers operational since 2023 under Measure 109
• Colorado — Natural Medicine Health Act operational 2024+
• Clinical trial participation — Free, includes medical supervision
• International — Netherlands (legal truffles), Jamaica (no legal prohibition), Australia (TGA-approved as of 2023)

See the Finding a Therapist and Oregon Therapy Guide pages for practical access information.