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Early Phase 1 landscape

Early Phase 1 Psilocybin Clinical Trials

Review psilocybin studies explicitly registered as Early Phase 1, with current recruitment status, populations, enrollment, sponsors, and locations.

Explore this trial map All recruiting trials

Registry status is not a guarantee of local availability, eligibility, safety, or efficacy. Confirm every participation decision in the authoritative ClinicalTrials.gov record.

24matching trials
11currently recruiting
21registry-listed sites

Registry facts checkedAug 10, 2026 01:26 UTC

Live registry synthesis

Status, geography, and study phase

Early Phase 1 is preserved as a distinct registry designation. It is not combined with ordinary Phase 1 records, supporting precise development-stage comparisons.

Recruitment status

  1. Recruiting11
  2. Completed5
  3. Not yet recruiting2
  4. Withdrawn2
  5. Unknown status2
  6. Suspended1
  7. Active, not recruiting1

Leading countries

  1. United States16
  2. United Kingdom2
  3. Switzerland2
  4. Israel1
  5. Brazil1

Trial phases

  1. Early Phase 124
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24 matching registry records

Every factual summary is crawlable without JavaScript. Use the direct registry link for current eligibility, contacts, and site availability.

RecruitingNCT07118332

Psilocybin as a Treatment for Chronic Pain in Smokers

Yale University

Conditions
Smokers With Chronic Pain
Phase
Early Phase 1
Enrollment
10 estimated
Locations
Department of Veterans Affairs, West Haven, Connecticut, United States
Registry updated
2026-08-03
Open registry recordTracker record
RecruitingNCT07737054

Trauma-informed Psilocybin Assisted Psychotherapy (TiPAP) for Post-Traumatic Stress Disorder

Tel-Aviv Sourasky Medical Center

Conditions
Post-Traumatic Stress Disorder, PTSD
Phase
Early Phase 1
Enrollment
13 estimated
Locations
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
Registry updated
2026-07-30
Open registry recordTracker record
RecruitingNCT07732166

Changes in Self-awareness Induced by Psychoactive Substances: an Experimental Study With Psilocybin.

Pontifícia Universidade Católica do Rio de Janeiro

Conditions
Healthy Adults
Phase
Early Phase 1
Enrollment
100 estimated
Locations
Centro de Pesquisas Matteo Ricci, Rio de Janeiro, Rio de Janeiro, Brazil
Registry updated
2026-07-28
Open registry recordTracker record
RecruitingNCT06464367

Mechanistic Studies of Psilocybin in Headache Disorders

Yale University

Conditions
Migraine
Phase
Early Phase 1
Enrollment
50 estimated
Locations
VA Connecticut Healthcare System, West Haven, Connecticut, United States
Registry updated
2026-07-13
Open registry recordTracker record
RecruitingNCT07565493

Psilocybin Administration With 5-HT1a Blockade

Johns Hopkins University

Conditions
Psychedelic Effects in Healthy Volunteers
Phase
Early Phase 1
Enrollment
18 estimated
Locations
Center for Psychedelics and Consciousness Research, Baltimore, Maryland, United States
Registry updated
2026-06-25
Open registry recordTracker record
Not yet recruitingNCT07449351

Effects of Psilocybin Microdosing on Cognition, Mood and Quality of Life: A Pilot Study

Yale University

Conditions
Psychedelic Microdosing Effects on Mood, Cognition, Subjective Well-being and MRI
Phase
Early Phase 1
Enrollment
20 estimated
Locations
Olin Neuropsychiatry Research Center, Hartford, Connecticut, United States
Registry updated
2026-06-23
Open registry recordTracker record
RecruitingNCT06724289

Psilocybin-Assisted Therapy for Prolonged Grief

University of Virginia

Conditions
Prolonged Grief Disorder
Phase
Early Phase 1
Enrollment
12 estimated
Locations
University of Virginia, Charlottesville, Virginia, United States
Registry updated
2026-06-23
Open registry recordTracker record
SuspendedNCT06102434

Safety Profile of 25 mg Psilocybin in Individuals With Cocaine Use Disorder

University of California, Los Angeles

Conditions
Cocaine Use Disorder
Phase
Early Phase 1
Enrollment
10 estimated
Locations
University of California, Los Angeles, Los Angeles, California, United States
Registry updated
2026-04-07
Open registry recordTracker record
Active, not recruitingNCT05546658

Effects of Psilocybin in Obsessive Compulsive Disorder

Johns Hopkins University

Conditions
Obsessive-Compulsive Disorder
Phase
Early Phase 1
Enrollment
35 actual
Locations
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
Registry updated
2026-04-02
Open registry recordTracker record
RecruitingNCT04123314

Pilot Study of Serotonin 2A Receptor (5-HT2A) Agonist Psilocybin for Depression in Patients With Mild Cognitive Impairment or Early Alzheimer's Disease

Johns Hopkins University

Conditions
Depressive Symptoms · Depression · Alzheimer Disease · Mild Cognitive Impairment
Phase
Early Phase 1
Enrollment
20 estimated
Locations
Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States
Registry updated
2026-03-16
Open registry recordTracker record
WithdrawnNCT05227742

Exploratory Study of the Effects of Low-Dose Psilocybin on Sensory Processing, Neurophysiological Arousal, and Emotional Health

University of Alabama at Birmingham

Conditions
Demoralization
Phase
Early Phase 1
Enrollment
0 actual
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Registry updated
2026-03-11
Open registry recordTracker record
RecruitingNCT05068791

Psilocybin-facilitated Treatment for Chronic Pain

University of Alabama at Birmingham

Conditions
Fibromyalgia, Primary
Phase
Early Phase 1
Enrollment
30 estimated
Locations
UAB Beacon Tower, Birmingham, Alabama, United States
Registry updated
2026-03-11
Open registry recordTracker record
Not yet recruitingNCT06760533

Pilot Proof of Concept Study Evaluating the Potential Psilocybin Assisted Psychotherapy (PAP) as a Therapeutic Tool for Patients Suffering From Severe Irritable Bowel Syndrome.

NYU Langone Health

Conditions
IBS - Irritable Bowel Syndrome
Phase
Early Phase 1
Enrollment
10 estimated
Locations
NYU Langone Health, New York, New York, United States
Registry updated
2026-03-05
Open registry recordTracker record
RecruitingNCT06656702

Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis

Johns Hopkins University

Conditions
Amyotrophic Lateral Sclerosis
Phase
Early Phase 1
Enrollment
24 estimated
Locations
Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States
Registry updated
2026-01-12
Open registry recordTracker record
RecruitingNCT06798636

Investigating the Effects of a Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm Behaviour: an Experimental Medicine Study

Imperial College London

Conditions
Self Harm
Phase
Early Phase 1
Enrollment
30 estimated
Locations
Imperial College London, London, United Kingdom
Registry updated
2025-12-05
Open registry recordTracker record
CompletedNCT04501653

Precision Functional Brain Mapping to Understand the Mechanisms of Psilocybin

Washington University School of Medicine

Conditions
Psilocybin
Phase
Early Phase 1
Enrollment
11 actual
Locations
Washington University, St Louis, Missouri, United States
Registry updated
2025-10-31
Open registry recordTracker record
RecruitingNCT06899594

A Pilot Study in North Louisiana to Assess the Tolerability of Psilocybin as Well as Its Capacity to Promote Abstinence From Methamphetamine

Kevin Murnane

Conditions
Methamphetamine Use Disorder
Phase
Early Phase 1
Enrollment
20 estimated
Locations
LSU Health Shreveport, Shreveport, Louisiana, United States
Registry updated
2025-10-07
Open registry recordTracker record
CompletedNCT04522804

A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer

University of Utah

Conditions
Cancer
Phase
Early Phase 1
Enrollment
12 actual
Locations
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Registry updated
2024-03-20
Open registry recordTracker record
CompletedNCT05780216

Mindfulness and Psychedelics: A Combined Neurophenomenological and Pharmacological Approach to the Characterization of Mindfulness States in Experienced Meditators

Milan Scheidegger

Conditions
Healthy Participants
Phase
Early Phase 1
Enrollment
40 actual
Locations
Psychiatric University Hospital Zurich, Zurich, Switzerland
Registry updated
2023-09-21
Open registry recordTracker record
Unknown statusNCT05958758

An Open Label Pragmatic Feasibility Study on a Resilience Focused Community of Practice Program With Psilocybin-assisted Therapy (PaT) for End-of-Life Patients.

The Roots to Thrive Society for Psychedelic Therapy

Conditions
End of Life
Phase
Early Phase 1
Enrollment
64 estimated
Locations
No mapped site reported
Registry updated
2023-07-25
Open registry recordTracker record
WithdrawnNCT05252598

Mood and Cognitive Effects of Low Doses of Psilocybin Observed in Healthy Subjects ("MELO"): A Blinded, Placebo-Controlled, Dose-Finding Study

Optimi Health Corporation

Conditions
Mood Disturbance · Mood Change · Sleep Disturbance · Drug Effect
Phase
Early Phase 1
Enrollment
0 actual
Locations
No mapped site reported
Registry updated
2023-03-20
Open registry recordTracker record
CompletedNCT03604744

Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin in a Random-order Placebo-controlled Cross-over Study in Healthy Subjects

University Hospital, Basel, Switzerland

Conditions
Healthy
Phase
Early Phase 1
Enrollment
28 actual
Locations
Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland
Registry updated
2021-04-27
Open registry recordTracker record
CompletedNCT00957359

Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients

NYU Langone Health

Conditions
Cancer
Phase
Early Phase 1
Enrollment
29 actual
Locations
NYU College of Dentistry Bluestone Center for Clinical Research, New York, New York, United States
Registry updated
2020-10-20
Open registry recordTracker record
Unknown statusNCT03661125

A Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis.

King's College London

Conditions
Parkinson Disease Psychosis
Phase
Early Phase 1
Enrollment
30 estimated
Locations
Mitul Mehta, London, Camberwell, United Kingdom
Registry updated
2019-08-13
Open registry recordTracker record
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