Phase 2 Psilocybin Clinical Trials

Not yet recruitingNCT07721467

Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin (NECTAR) in Aging and Alzheimer's Disease

Conditions: Alzheimer's Disease
Phase: Phase 2
Enrollment: 200 estimated
Locations: National Institute of Aging, Clinical Research Unit, Baltimore, Maryland, United States
Registry updated: 2026-08-07

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RecruitingNCT06349083

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder

Conditions: Alcohol Use Disorder
Phase: Phase 2
Enrollment: 200 estimated
Locations: NYU Langone Health, New York, New York, United States
Registry updated: 2026-08-07

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RecruitingNCT06455293

The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease

Conditions: Parkinson Disease · Depression
Phase: Phase 2
Enrollment: 60 estimated
Locations: University of California, San Francisco, San Francisco, California, United States
Registry updated: 2026-08-07

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RecruitingNCT06233344

An Exploratory Study of Feasibility, Efficacy, and Mechanisms of Mindfulness-Assisted Psychedelic Therapy

Conditions: Mental Health
Phase: Phase 2
Enrollment: 40 estimated
Locations: Univeristy of Southern California Brain and Creativity Institute, Los Angeles, California, United States
Registry updated: 2026-08-06

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RecruitingNCT06001749

Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer

Conditions: Opioid-Related Disorders · Pain Management · Pain Management and Care · Advanced Cancer
Phase: Phase 2
Enrollment: 15 estimated
Locations: Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Registry updated: 2026-08-05

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Not yet recruitingNCT07745569

Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

Conditions: PTSD · PTSD - Post Traumatic Stress Disorder · Major Depression · Suicidality
Phase: Phase 2
Enrollment: 150 estimated
Locations: No mapped site reported
Registry updated: 2026-08-04

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Active, not recruitingNCT07336238

A Phase 2a Study of Group Retreat Psilocybin Therapy for Cancer-Related Anxiety and Depression

Conditions: Anxiety · Depression · Hematopoietic and Lymphatic System Neoplasm · Metastatic Malignant Solid Neoplasm
Phase: Phase 2
Enrollment: 18 estimated
Locations: Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
Registry updated: 2026-07-31

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RecruitingNCT06512220

Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)

Conditions: Treatment Resistant Depression
Phase: Phase 2
Enrollment: 12 estimated
Locations: Centre for Addiction and Mental Health, Toronto, Ontario, Canada
Registry updated: 2026-07-30

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RecruitingNCT06518720

Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND): An Open-Label Clinical Trial

Conditions: Treatment Resistant Depression · Chronic Pain
Phase: Phase 2
Enrollment: 16 estimated
Locations: Centre for Addiction and Mental Health, Toronto, Ontario, Canada
Registry updated: 2026-07-30

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RecruitingNCT06706232

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

Conditions: Bipolar II Disorder · Depression, Bipolar · Suicidality
Phase: Phase 2
Enrollment: 10 estimated
Locations: The University of Texas Health Science Center at Houston, Houston, Texas, United States
Registry updated: 2026-07-30

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RecruitingNCT07211438

Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression: A Pilot Randomized Clinical Trial

Conditions: Treatment-Resistant Depression
Phase: Phase 2
Enrollment: 40 estimated
Locations: Toronto Western Hospital (University Health Network), Toronto, Ontario, Canada · Centre for Addiction and Mental Health, Toronto, Ontario, Canada
Registry updated: 2026-07-30

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RecruitingNCT06200155

TRIP - TReatment to Improve Depression and/or Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

Conditions: Depression, Anxiety · Psilocybin-Assisted Psychotherapy · Advanced Cancer
Phase: Phase 2
Enrollment: 30 estimated
Locations: MD Anderson Cancer Center, Houston, Texas, United States
Registry updated: 2026-07-29

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RecruitingNCT06801041

TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors

Conditions: Depression · Anxiety · Cancer
Phase: Phase 2
Enrollment: 20 estimated
Locations: The University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States
Registry updated: 2026-07-29

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Not yet recruitingNCT07227909

NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy

Conditions: Psilocybin · Neuropathy
Phase: Phase 2
Enrollment: 83 estimated
Locations: MD Anderson Cancer Center, Houston, Texas, United States
Registry updated: 2026-07-29

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RecruitingNCT05301608

Effects of Psilocybin on Electrophysiology and the Dynamic Content of Thought

Conditions: Healthy
Phase: Phase 1 · Phase 2
Enrollment: 30 estimated
Locations: Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States
Registry updated: 2026-07-23

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RecruitingNCT06820723

A Randomized, Double-Blind, Placebo-Controlled Mechanistic Study to Assess a Single Oral Dose of CYB003 in Participants With Major Depressive Disorder (MDD) and Moderate to Severe Anxiety

Conditions: Depression · Anxiety · Major Depressive Disorder
Phase: Phase 2
Enrollment: 40 estimated
Locations: The Ohio State University Department of Psychiatry, Columbus, Ohio, United States
Registry updated: 2026-07-23

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RecruitingNCT07610135

PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Conditions: Mood (Psychological Function) · Well Being · Mood · Healthy
Phase: Phase 1 · Phase 2
Enrollment: 20 estimated
Locations: Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States
Registry updated: 2026-07-21

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RecruitingNCT06814522

Psilocybin-Assisted Therapy for Physician Well-Being and Burnout: Feasibility, Safety, Clinical Effectiveness and Biomarkers of Response [PAT-B (Psilocybin-Assisted Therapy for Physician Well-Being and Burnout)]

Conditions: Burnout · Burnout, Healthcare Workers
Phase: Phase 1 · Phase 2
Enrollment: 10 estimated
Locations: UC San Diego, San Diego, California, United States
Registry updated: 2026-07-21

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RecruitingNCT07610369

The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease

Conditions: Depression · Parkinson's Disease (PD)
Phase: Phase 2
Enrollment: 40 estimated
Locations: Yale University, New Haven, Connecticut, United States
Registry updated: 2026-07-20

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RecruitingNCT06067737

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

Conditions: Opioid Use Disorder
Phase: Phase 2
Enrollment: 90 estimated
Locations: Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States
Registry updated: 2026-07-17

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Not yet recruitingNCT07306364

Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes

Conditions: Chronic Low Back Pain (CLBP) · Physical Therapy · Psilocybin
Phase: Phase 2
Enrollment: 45 estimated
Locations: Connecticut Mental Health Center, New Haven, Connecticut, United States
Registry updated: 2026-07-16

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Active, not recruitingNCT04754061

PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site, Open-label, Single Arm Phase I/II Proof-of-concept, Dose-finding, and Feasibility Clinical Trial

Conditions: Depression, Anxiety · Distress, Emotional
Phase: Phase 1 · Phase 2
Enrollment: 20 estimated
Locations: The Ottawa Hospital, Ottawa, Ontario, Canada · Bruyere Continuing Care, Ottawa, Ontario, Canada
Registry updated: 2026-07-10

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Active, not recruitingNCT06341426

Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: A Randomized Phase II Clinical Trial Comparing One Versus Two Psychedelic Doses of Psilocybin (PSI-1V2)

Conditions: Major Depressive Disorder · Depression · Treatment-Resistant Depression · Mood Disorders
Phase: Phase 2
Enrollment: 92 estimated
Locations: Toronto Western Hospital, Toronto, Ontario, Canada · Centre for Addiction and Mental Health (CAMH), Toronto, Ontario, Canada
Registry updated: 2026-07-09

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RecruitingNCT06810310

Psilocybin: Capturing Brain Mechanisms of Motivation and Neurocognition in Individuals With Opioid Use Disorder

Conditions: Opioid Use Disorder
Phase: Phase 2
Enrollment: 24 estimated
Locations: University of Pennsylvania, Philadelphia, Pennsylvania, United States
Registry updated: 2026-07-09

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RecruitingNCT06902974

A Phase 2, Open-Label Study Investigating the Safety and Efficacy of Psilocybin-Assisted Therapy for Sexual Assault-Related Posttraumatic Stress Disorder (PTSD)

Conditions: Post Traumatic Stress Disorder · PTSD
Phase: Phase 2
Enrollment: 70 estimated
Locations: Sunstone Medical, PC, Rockville, Maryland, United States
Registry updated: 2026-07-01

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RecruitingNCT05452772

5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder

Conditions: Tobacco Use Disorder
Phase: Phase 2
Enrollment: 66 estimated
Locations: University of Alabama at Birmingham, Birmingham, Alabama, United States · Johns Hopkins University School of Medicine, Baltimore, Maryland, United States · New York University, New York, New York, United States
Registry updated: 2026-06-29

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RecruitingNCT06386003

Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: An Open-label Trial

Conditions: Post Traumatic Stress Disorder · PTSD · Chronic PTSD
Phase: Phase 2
Enrollment: 15 estimated
Locations: St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada
Registry updated: 2026-06-26

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RecruitingNCT07104916

A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (PTSD)

Conditions: Post Traumatic Stress Disorder · Depression - Major Depressive Disorder
Phase: Phase 2
Enrollment: 30 estimated
Locations: The Ohio State University Medical Center, Columbus, Ohio, United States
Registry updated: 2026-06-25

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RecruitingNCT07048743

Psilocybin-assisted Existential, Attachment and Relational (PEARL) Therapy for Caregivers of Patients With Advanced Cancer: A Phase II Open-Label Trial

Conditions: Caregiver Distress
Phase: Phase 2
Enrollment: 15 estimated
Locations: Toronto General Hospital, Toronto, Ontario, Canada
Registry updated: 2026-06-23

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Not yet recruitingNCT06827054

Low-Dose Psilocybin Therapy for Palliative Care Patients With Chronic Cancer Pain Requiring Opioids

Conditions: Hematopoietic and Lymphatic System Neoplasm · Malignant Solid Neoplasm
Phase: Phase 2
Enrollment: 20 estimated
Locations: Roswell Park Cancer Institute, Buffalo, New York, United States
Registry updated: 2026-06-22

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Active, not recruitingNCT06416085

Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer: A Phase II Open-Label Trial

Conditions: Advanced Cancer · Stage IV Solid Tumor Cancer · Stage IV Sarcoma of Bone · Stage IV Lymphoma
Phase: Phase 2
Enrollment: 15 estimated
Locations: Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Registry updated: 2026-06-22

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Not yet recruitingNCT07079852

The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function

Conditions: Healthy
Phase: Phase 1 · Phase 2
Enrollment: 48 estimated
Locations: The University of Texas at Austin Dell Medical School, Austin, Texas, United States
Registry updated: 2026-06-15

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Not yet recruitingNCT07296094

Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder: A Double-Blind, Dose-Comparison Concurrent Control Randomized Trial

Conditions: Alcohol Use Disorder
Phase: Phase 2
Enrollment: 36 estimated
Locations: Brigham and Women's Hospital, Boston, Massachusetts, United States
Registry updated: 2026-06-15

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RecruitingNCT06626139

2 x 2 Factorial, Double-blind, Randomized Trial of 'Set and Setting': a Translational Study in Healthy Volunteers

Conditions: Healthy Participants With Lower-than-average Mental Well-being
Phase: Phase 2
Enrollment: 120 estimated
Locations: UCSF Mission Bay, San Francisco, California, United States
Registry updated: 2026-06-04

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RecruitingNCT06768944

The Role of the Subjective Experience in Supporting Positive Effects Following Psilocybin: a Randomized, Controlled Clinical Trial Using Risperidone in Healthy Adults

Conditions: Investigating the Importance of the Subjective Psychedelic Experience
Phase: Phase 2
Enrollment: 128 estimated
Locations: University of Calgary, Calgary, Alberta, Canada
Registry updated: 2026-06-02

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Not yet recruitingNCT07332143

The Safety and Acceptability of Psilocybin With Support and With Massed Prolonged Exposure Therapy for PTSD

Conditions: PTSD
Phase: Phase 2
Enrollment: 150 estimated
Locations: Emory University Hospital, Atlanta, Georgia, United States
Registry updated: 2026-05-26

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CompletedNCT06230757

Effects of Psilocybin With Psychological Support on Anhedonia in Treatment-resistant Depression: a Randomized Controlled Pilot Trial

Conditions: Major Depressive Disorder · Anhedonia · Treatment Resistant Depression
Phase: Phase 2
Enrollment: 20 actual
Locations: University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
Registry updated: 2026-05-22

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Not yet recruitingNCT07582120

A Pilot Mechanistic Study of Psilocybin-Assisted Therapy as a Treatment for Depression

Conditions: Depression
Phase: Phase 2
Enrollment: 50 estimated
Locations: Washington University School of Medicine, St Louis, Missouri, United States
Registry updated: 2026-05-20

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CompletedNCT02037126

Psilocybin-facilitated Treatment for Cocaine Use

Conditions: Cocaine-Related Disorders
Phase: Phase 2
Enrollment: 40 actual
Locations: UAB Outpatient Clinical Research Unit, Birmingham, Alabama, United States
Registry updated: 2026-05-18

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RecruitingNCT07216404

Exploring the Safety, Acceptability, and Efficacy of Psilocybin Among Non-Small Cell Lung Cancer Patients With Major Depressive Disorder: A Proof-of-Concept Trial (DREAM LUNG STUDY)

Conditions: Lung Non-Small Cell Carcinoma · Unipolar Depression
Phase: Phase 2
Enrollment: 10 estimated
Locations: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Registry updated: 2026-05-14

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Not yet recruitingNCT06885996

Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence

Conditions: Post Traumatic Stress Disorder PTSD · Intimate Partner Violence (IPV)
Phase: Phase 2
Enrollment: 76 estimated
Locations: University of Calgary, Calgary, Alberta, Canada · The University of British Columbia - Okanagan Campus, Kelowna, British Columbia, Canada
Registry updated: 2026-05-14

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Not yet recruitingNCT06992999

Psilocybin for Treatment of Obsessive Compulsive Disorder

Conditions: Obsessive - Compulsive Disorder
Phase: Phase 1 · Phase 2
Enrollment: 20 estimated
Locations: University of Arizona-Tucson, Tucson, Arizona, United States
Registry updated: 2026-05-12

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Not yet recruitingNCT07570654

A Phase 2b/3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

Conditions: PTSD - Post Traumatic Stress Disorder · PTSD · PTSD Symptoms · PTSD, Post Traumatic Stress Disorder
Phase: Phase 2 · Phase 3
Enrollment: 300 estimated
Locations: No mapped site reported
Registry updated: 2026-05-12

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RecruitingNCT06782724

The Safety and Efficacy of Psilocybin Therapy Compared to Low-dose Control in Reducing Depressive Symptoms in Patients With COPD, ALS, MS, or APD.

Conditions: COPD (Chronic Obstructive Pulmonary Disease) · ALS (Amyotrophic Lateral Sclerosis) · MS (Multiple Sclerosis) · Major Depressive Disorder (MDD)
Phase: Phase 2
Enrollment: 108 estimated
Locations: National Institute of Mental Health, Prague, Czechia · Bispebjerg Hospital, Copenhagen, Denmark · University Medical Center Groningen, Groningen, Provincie Groningen, Netherlands · +1 more
Registry updated: 2026-05-08

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CompletedNCT05710237

Does Psilocybin Require Psychedelic Effects to Treat Depression? A 4-Week, Double-Blind, Proof-of-Concept Randomized Controlled Trial

Conditions: Treatment-resistant Depression
Phase: Phase 2
Enrollment: 41 actual
Locations: Centre for Addiction and Mental Health, Toronto, Ontario, Canada
Registry updated: 2026-05-07

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Active, not recruitingNCT05947383

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer

Conditions: Cancer · Major Depressive Disorder
Phase: Phase 2
Enrollment: 56 estimated
Locations: Sunstone Medical, PC, Rockville, Maryland, United States
Registry updated: 2026-05-06

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Not yet recruitingNCT07479550

A Phase 2 Randomized Study Examining the Safety, Feasibility, and Effectiveness of Masking Psilocybin Therapy With General Anesthesia in Major Depressive Disorder

Conditions: Major Depression
Phase: Phase 2
Enrollment: 10 estimated
Locations: Stanford University, Stanford, California, United States
Registry updated: 2026-05-06

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Not yet recruitingNCT07565909

A Phase 2 Sequential Dose-Finding Study of Preparation for Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression

Conditions: Depression · Anxiety
Phase: Phase 2
Enrollment: 72 estimated
Locations: No mapped site reported
Registry updated: 2026-05-04

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RecruitingNCT07251491

Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury

Conditions: Spinal Cord Injury · Depression - Major Depressive Disorder · Veteran
Phase: Phase 1 · Phase 2
Enrollment: 30 estimated
Locations: James J. Peters Department of Veterans Affairs Medical Center, The Bronx, New York, United States
Registry updated: 2026-05-04

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Not yet recruitingNCT07566104

Group Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder

Conditions: Depression - Major Depressive Disorder · Psilocybin · Cognitive Behavioral Therapy
Phase: Phase 2
Enrollment: 30 estimated
Locations: UCLA Semel Institute, Los Angeles, California, United States
Registry updated: 2026-05-04

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RecruitingNCT05883540

Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)

Conditions: Palliative Care · Pain · Anxiety · Depression
Phase: Phase 2
Enrollment: 60 estimated
Locations: University Hospital Basel, Division of Clinical Pharmacology and Toxicology, Basel, Switzerland · University Hospital Geneva, Palliative medicine department, Collonge-Bellerive, Switzerland · Spital Uster AG, Division of Internal Medicine, Uster, Switzerland · +1 more
Registry updated: 2026-04-29

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Active, not recruitingNCT05351541

A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain

Conditions: Chronic Low-back Pain
Phase: Phase 1 · Phase 2
Enrollment: 30 estimated
Locations: University of California San Francisco, San Francisco, California, United States
Registry updated: 2026-04-29

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Active, not recruitingNCT04982796

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Conditions: Amphetamine-Related Disorders
Phase: Phase 1 · Phase 2
Enrollment: 30 estimated
Locations: Portland VA Health Care System, Vancouver, Washington, United States
Registry updated: 2026-04-22

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CompletedNCT03866174

A Randomized, Double-Blind Study of Single-Dose Psilocybin for Major Depressive Disorder (MDD)

Conditions: Depressive Disorder, Major
Phase: Phase 2
Enrollment: 347 actual
Locations: University of California, San Francisco, San Francisco, California, United States · Pacific Neuroscience Institute, Santa Monica, California, United States · Yale University, New Haven, Connecticut, United States · +8 more
Registry updated: 2026-04-22

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Not yet recruitingNCT07373535

Toward Patient-Tailored Care for Treatment-Resistant Depression: A Pilot Patient-Preference Clinical Trial of Music and Mindfulness in Psilocybin-Assisted Psychotherapy

Conditions: Treatment-Resistant Major Depressive Disorder
Phase: Phase 2
Enrollment: 16 estimated
Locations: Jewish General Hospital, Montreal, Quebec, Canada
Registry updated: 2026-04-22

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RecruitingNCT06319378

CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial

Conditions: MDD
Phase: Phase 2
Enrollment: 100 estimated
Locations: region Västra Götaland, Gothenburg, Göteborg, Sweden · Norra Stockholms Psykiatri, Stockholm, Stockholm County, Sweden · Psykiatriska Kliniken, Akademiska Sjukhuset, Uppsala, Uppsala County, Sweden · +1 more
Registry updated: 2026-04-13

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RecruitingNCT06072898

Engaging Mood Brain Circuits With Psilocybin: a Randomized Neuroimaging Trial in Depression

Conditions: Depressive Disorder · Major Depressive Disorder
Phase: Phase 2
Enrollment: 50 estimated
Locations: Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Registry updated: 2026-03-30

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Not yet recruitingNCT07499583

Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder

Conditions: Treatment Resistant Depression · Substance Use Disorders
Phase: Phase 1 · Phase 2
Enrollment: 50 estimated
Locations: Goodman Hall, Dept of Psychiatry, Indiana University, Indianapolis, Indiana, United States · The Stark Neuroscience Building (Goodman Hall), Indianapolis, Indiana, United States
Registry updated: 2026-03-30

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RecruitingNCT06898606

Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression

Conditions: Depressive Disorder
Phase: Phase 1 · Phase 2
Enrollment: 24 estimated
Locations: Federal University of Latin American Integration, Foz do Iguaçu, Paraná, Brazil
Registry updated: 2026-03-27

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CompletedNCT05416229

The QUANTUM Trip Trial - Psilocybin-assisted Therapy for Reducing Alcohol Intake in Patients With Alcohol Use Disorder: A Randomized, Double-blinded, Placebo-controlled Clinical Trial.

Conditions: Alcohol Use Disorder
Phase: Phase 2
Enrollment: 60 actual
Locations: Psychiatric Center Copenhagen, Frederiksberg Hospital, Frederiksberg, Denmark
Registry updated: 2026-03-24

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WithdrawnNCT07484906

Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

Conditions: Suicidal Ideation
Phase: Phase 2
Enrollment: 0 actual
Locations: No mapped site reported
Registry updated: 2026-03-20

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Active, not recruitingNCT04620759

Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder

Conditions: Major Depressive Disorder · Alcohol Use Disorder
Phase: Phase 2
Enrollment: 90 estimated
Locations: Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States
Registry updated: 2026-03-13

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RecruitingNCT07169747

The Therapeutic Potential of Psilocybin in Anorexia Nervosa in Young Adults

Conditions: Anorexia Nervosa
Phase: Phase 2
Enrollment: 40 estimated
Locations: Psykiatrikliniken, Baravägen 1, Lund, Sweden
Registry updated: 2026-03-06

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Active, not recruitingNCT05554094

Examining the Safety and Clinical Efficacy of Psilocybin Therapy for Veterans With PTSD: An Open-Label Proof-of-Concept Trial

Conditions: PTSD · Stress Disorders, Traumatic · Stress Disorders, Post-Traumatic · Trauma and Stressor Related Disorders
Phase: Phase 2
Enrollment: 15 estimated
Locations: Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center, Columbus, Ohio, United States
Registry updated: 2026-03-04

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RecruitingNCT07072728

A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.

Conditions: Adjustment Disorder · Adjustment Disorder With Anxious Mood · Cancer · Cancer Cachexia
Phase: Phase 2
Enrollment: 87 estimated
Locations: Mind Medicine Australia Clinic, Abbotsford, Victoria, Australia · Paratus Clinical Research Melbourne, Northcote, Victoria, Australia · Empax Centre, Leederville, Western Australia, Australia
Registry updated: 2026-03-03

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RecruitingNCT06399263

Study of Psilocybin for Anorexia in Young Adults

Conditions: Anorexia Nervosa
Phase: Phase 2
Enrollment: 40 estimated
Locations: University of California, San Francisco, San Francisco, California, United States
Registry updated: 2026-03-03

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Active, not recruitingNCT06041152

Does Psilocybin Change Synaptic Density in the Brains of Patients With Amnestic Mild Cognitive Impairment

Conditions: Amnestic Mild Cognitive Impairment
Phase: Phase 2
Enrollment: 10 actual
Locations: Centre for Addiction and Mental Health, Toronto, Ontario, Canada
Registry updated: 2026-02-25

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WithdrawnNCT06005662

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

Conditions: Opioid Use Disorder
Phase: Phase 2
Enrollment: 0 actual
Locations: Johns Hopkins University, Baltimore, Maryland, United States
Registry updated: 2026-02-23

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CompletedNCT04950608

Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care - PATH Study

Conditions: Hospice · Psilocybin · Demoralization · Terminal Illness
Phase: Phase 2
Enrollment: 15 actual
Locations: Care Dimensions, Danvers, Massachusetts, United States
Registry updated: 2026-02-17

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Not yet recruitingNCT07405606

Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder: A Pilot Randomized Clinical Trial

Conditions: Major Depressive Disorder (MDD) · Alcohol Use Disorder (AUD)
Phase: Phase 2
Enrollment: 30 estimated
Locations: Centre for Addiction and Mental Health, Toronto, Ontario, Canada
Registry updated: 2026-02-12

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RecruitingNCT07281352

Psilocybin-Assisted Cognitive Behavioral Therapy for Depression

Conditions: Major Depressive Diorder
Phase: Phase 1 · Phase 2
Enrollment: 50 estimated
Locations: UCLA Semel Institute, Los Angeles, California, United States
Registry updated: 2026-02-12

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Active, not recruitingNCT06206265

A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Oral Psilocybin (TRP-8802) Administration in Concert With Psychotherapy Among Adult Patients With Irritable Bowel Syndrome: A Randomized Delayed Treatment Control Design

Conditions: Irritable Bowel Syndrome
Phase: Phase 2
Enrollment: 14 actual
Locations: Massachusetts General Hospital, Boston, Massachusetts, United States
Registry updated: 2026-02-05

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Not yet recruitingNCT07391332

Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER: a Pilot Study

Conditions: Gambling Disorder
Phase: Phase 2
Enrollment: 30 estimated
Locations: Nantes University Hospital, Nantes, France
Registry updated: 2026-02-05

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RecruitingNCT06796062

A Phase 2 Trial of Psilocybin as an Adjunctive Treatment for OUD Patients Who Continue to Use Illicit Opioids Despite Adherence to Methadone Treatment

Conditions: Opioid Use Disorder
Phase: Phase 2
Enrollment: 480 estimated
Locations: Duke City Recovery Toolbox, Albuquerque, New Mexico, United States · University of New Mexico, Albuquerque, New Mexico, United States · StartCare, Brooklyn, New York, United States · +2 more
Registry updated: 2026-01-23

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RecruitingNCT06888128

The STARLIGHT Protocol: State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma

Conditions: PTSD
Phase: Phase 2
Enrollment: 15 estimated
Locations: Baylor College of Medicine, Houston, Texas, United States
Registry updated: 2026-01-22

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CompletedNCT05259943

Microdosing Psychedelics to Improve Mood

Conditions: Major Depressive Disorder
Phase: Phase 2
Enrollment: 39 actual
Locations: Psych Research, Toronto, Ontario, Canada
Registry updated: 2025-12-30

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CompletedNCT05220410

The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation

Conditions: Treatment Resistant Depression · Suicidal Ideation
Phase: Phase 2
Enrollment: 20 actual
Locations: Sheppard Pratt Health System, Baltimore, Maryland, United States
Registry updated: 2025-12-24

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CompletedNCT05399498

An Open Label Study of Single-Dose Psilocybin for Major Depressive Disorder With Co-occurring Borderline Personality Disorder

Conditions: Borderline Personality Disorder · Major Depressive Disorder
Phase: Phase 2
Enrollment: 9 actual
Locations: University of Chicago, Chicago, Illinois, United States
Registry updated: 2025-12-23

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Not yet recruitingNCT07296328

Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter

Conditions: Stuttering
Phase: Phase 2
Enrollment: 25 estimated
Locations: NYU Langone Health, New York, New York, United States
Registry updated: 2025-12-22

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RecruitingNCT05585229

Standardized Natural Psilocybin-assisted Psychotherapy for Tapering of Opioid Medication in Patients With Chronic Pain: an Open-label Feasibility Study

Conditions: Opioid Dependence · Chronic Pain
Phase: Phase 2
Enrollment: 10 estimated
Locations: University of British Columbia - Okanagan Campus, Kelowna, British Columbia, Canada
Registry updated: 2025-12-04

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RecruitingNCT05398484

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer

Conditions: Advanced Cancer
Phase: Phase 2 · Phase 3
Enrollment: 200 estimated
Locations: University of Colorado Anschutz Medical campus (CU AMC), Aurora, Colorado, United States · NYU Langone Health, New York, New York, United States
Registry updated: 2025-12-04

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RecruitingNCT06405607

Psilocybin vs Ketamine for Alcohol Use Disorder

Conditions: Alcohol Use Disorder · Alcohol Dependence · Alcohol Abuse
Phase: Phase 2
Enrollment: 80 estimated
Locations: University of Iowa Health Care, Iowa City, Iowa, United States
Registry updated: 2025-11-28

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RecruitingNCT06132178

Assessing the Safety, Tolerability, and Efficacy of Psilocybin Therapy Followed by Accelerated Intermittent Theta Burst (aiTBS) Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Major Depressive Disorder

Conditions: Treatment Resistant Depression · MDD · Major Depressive Disorder · Recurrent Depression
Phase: Phase 2
Enrollment: 100 estimated
Locations: Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600, Austin, Texas, United States
Registry updated: 2025-11-26

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RecruitingNCT05403086

Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC): A Multicenter Triple-blind Phase 2 Randomized Controlled Trial of Psilocybin Therapy for Demoralized Adults Near the End of Life

Conditions: Demoralization
Phase: Phase 2
Enrollment: 100 estimated
Locations: Marin Cancer Care, Greenbrae, California, United States · University of California, Los Angeles, Los Angeles, California, United States · University of San Francisco, San Francisco, California, United States · +2 more
Registry updated: 2025-11-25

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RecruitingNCT07183748

A Double-blind, Phase II Feasibility Study to Assess the Safety and Efficacy of Psilocybin Microdosing Combined With Psychotherapy in Treatment-resistant Depression

Conditions: Treatment Resistant Depression
Phase: Phase 2
Enrollment: 20 estimated
Locations: Mental Health Center Beer Sheva, Beersheba, Israel
Registry updated: 2025-11-19

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RecruitingNCT04882839

Open Label, Phase 2 Study for Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe Obsessive Compulsive Disorder (OCD) in Drug and/or Psychotherapy Resistant Patients.

Conditions: Obsessive-compulsive Disorder
Phase: Phase 2
Enrollment: 15 estimated
Locations: Beer Sheva Mental Health Center, Beersheba, Israel
Registry updated: 2025-11-19

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Active, not recruitingNCT05421065

Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder

Conditions: Alcohol Use Disorder
Phase: Phase 2
Enrollment: 20 estimated
Locations: University of Iowa, Iowa City, Iowa, United States
Registry updated: 2025-11-17

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CompletedNCT05847686

A Phase 1/2 Study of a Group Model of Psilocybin-Assisted Therapy for Cancer-Related Anxiety in Patients With Metastatic Cancer

Conditions: Hematopoietic and Lymphatic System Neoplasm · Metastatic Malignant Solid Neoplasm
Phase: Phase 1 · Phase 2
Enrollment: 55 actual
Locations: Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
Registry updated: 2025-11-05

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RecruitingNCT06786325

A Wellcome Leap for the Opioid Crisis: Can the 5HT2A Agonist Psilocybin Improve Brain, Behavioral, and Clinical Outcomes in Opioid Use Disorder (OUD)?

Conditions: Opioid Use Disorder
Phase: Phase 2
Enrollment: 36 estimated
Locations: University of Pennsylvania, Philadelphia, Pennsylvania, United States
Registry updated: 2025-10-29

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Not yet recruitingNCT07210112

Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)

Conditions: Depression - Major Depressive Disorder · Treatment-resistant Depression (TRD)
Phase: Phase 2
Enrollment: 112 estimated
Locations: GHU Paris Psychiatrie and Neurosciences, Paris, France
Registry updated: 2025-10-07

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RecruitingNCT06899165

Processing Intergenerational Trauma With Psilocybin-Assisted Therapy

Conditions: Psychological Stress · Depression · Anxiety
Phase: Phase 2
Enrollment: 100 estimated
Locations: The Parsons Research Center for Psychedelic Healing, New York, New York, United States
Registry updated: 2025-09-08

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CompletedNCT06746441

Effect of Psilocybin Only and Psilocybin Assisted Cognitive Behavioral Therapy in the Management of Major Depressive Disorder and Associated Metabolic, Immune, Inflammatory, Neuroplasticity and Electrical Activity Markers: a Randomized Controlled Trial

Conditions: Major Depressive Disorder
Phase: Phase 2
Enrollment: 60 actual
Locations: Lady Reading Hospital, Pakistan, Peshawar, Khyber Pakhtunkhwa, Pakistan
Registry updated: 2025-09-02

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RecruitingNCT06853912

A Phase 2 Single-site, Double-blind, Placebo-controlled, Randomized Clinical Trial With an Open-label Extension Phase to Examine the Safety, Subjective Experiences, Acute Effects, and Suitability of Psilocybin Combined With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)

Conditions: Alcohol Use Disorder (AUD) · PTSD
Phase: Phase 2
Enrollment: 40 estimated
Locations: University of Washington Center for Novel Therapeutics in Addiction Psychiatry, Seattle, Washington, United States
Registry updated: 2025-08-28

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Active, not recruitingNCT05733546

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

Conditions: Major Depressive Disorder
Phase: Phase 2
Enrollment: 102 actual
Locations: Kadima Neuropsychiatry Institute, La Jolla, California, United States · Clinical Neuroscience Solutions Inc, Jacksonville, Florida, United States · Sunstone Therapies, Rockville, Maryland, United States · +2 more
Registry updated: 2025-08-19

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CompletedNCT05312151

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

Conditions: Post Traumatic Stress Disorder
Phase: Phase 2
Enrollment: 22 actual
Locations: Sunstone Therapies, Rockville, Maryland, United States · Icahn School of Medicine at Mount Sinai, New York, New York, United States · Kings College London, Institute of Psychiatry, Psychology and Neurology, London, United Kingdom
Registry updated: 2025-06-13

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RecruitingNCT06512194

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

Conditions: Depression
Phase: Phase 2
Enrollment: 141 estimated
Locations: Vail Health Behavioral Health, Edwards, Colorado, United States
Registry updated: 2025-05-23

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RecruitingNCT06592833

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

Conditions: Major Depressive Disorder
Phase: Phase 2
Enrollment: 60 estimated
Locations: Icahn School of Medicine at Mount Sinai, Center for Psychedelic Therapy Research, New York, New York, United States
Registry updated: 2025-05-14

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RecruitingNCT06969170

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

Conditions: Generalized Anxiety Disorder (GAD)
Phase: Phase 2
Enrollment: 50 estimated
Locations: Kingston General Health Research Institute, Kingston, Ontario, Canada
Registry updated: 2025-05-13

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CompletedNCT05128162

A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Psilocybin Administration in Concert With Psychotherapy Among Adult Patients With Fibromyalgia

Conditions: Fibromyalgia
Phase: Phase 2
Enrollment: 17 actual
Locations: Chronic Pain and Fatigue Research Center, Ann Arbor, Michigan, United States
Registry updated: 2025-04-16

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RecruitingNCT06731335

Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN

Conditions: Chronic Neuropathic Pain · Pain Management
Phase: Phase 2
Enrollment: 30 estimated
Locations: St. Michael's Hospital. Unity Health Toronto, Toronto, Ontario, Canada
Registry updated: 2025-03-30

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RecruitingNCT06225232

An 8-week Phase 2 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Psilocybin-assisted-psychotherapy in Adults With Cannabis Use Disorder: A Proof-of-Concept Study

Conditions: Cannabis Use Disorder, Moderate · Cannabis Use Disorder, Severe
Phase: Phase 2
Enrollment: 16 estimated
Locations: MacAnxiety Research Centre, Hamilton, Ontario, Canada
Registry updated: 2025-03-19

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CompletedNCT00302744

Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety

Conditions: Anxiety
Phase: Phase 1 · Phase 2
Enrollment: 12 actual
Locations: Harbor-UCLA Medical Center, Torrance, California, United States
Registry updated: 2025-03-13

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CompletedNCT04670081

A Phase II Randomized, Double-blind, Active Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Psilocybin in Treatment-resistant Major Depression

Conditions: Treatment-resistant Depression
Phase: Phase 2
Enrollment: 144 actual
Locations: Charité Berlin, Campus Mitte, Department of Psychiatry and Psychotherapy, Berlin, Germany · Central Institute of Mental Health (CIMH), Mannheim, Germany
Registry updated: 2025-01-20

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CompletedNCT04932434

Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study

Conditions: Parkinson Disease · Depression · Anxiety
Phase: Phase 2
Enrollment: 12 actual
Locations: University of California, San Francisco, San Francisco, California, United States
Registry updated: 2025-01-01

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CompletedNCT05481736

Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study

Conditions: Anorexia Nervosa
Phase: Phase 2
Enrollment: 32 actual
Locations: Altman Clinical and Translational Research Institute, San Diego, California, United States · Sheppard Pratt Health System, Baltimore, Maryland, United States · Dell Medical School, Austin, Texas, United States · +2 more
Registry updated: 2024-12-04

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CompletedNCT05035927

A Phase 2a Safety and Feasibility Study Evaluating Psilocybin (TRP-8802) Administration in Concert With Psychotherapy in the Treatment of Binge Eating Disorder

Conditions: Binge Eating Disorder
Phase: Phase 2
Enrollment: 5 actual
Locations: University of Florida, Gainesville, Florida, United States
Registry updated: 2024-11-19

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Not yet recruitingNCT06666010

A Registered Clinical Trial of PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study

Conditions: Stimulant Use Disorder
Phase: Phase 2
Enrollment: 86 estimated
Locations: No mapped site reported
Registry updated: 2024-10-30

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CompletedNCT03429075

Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms

Conditions: Depressive Disorder, Major
Phase: Phase 2
Enrollment: 59 actual
Locations: Imperial College Hammersmith campus, London, United Kingdom
Registry updated: 2024-10-24

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Active, not recruitingNCT05065294

An Open-Label Pilot Study Examining the Feasibility, Safety, and Effectiveness of Psilocybin Therapy for Depression in Bipolar II Disorder

Conditions: Bipolar II Disorder
Phase: Phase 2
Enrollment: 14 estimated
Locations: University of California, San Francisco, San Francisco, California, United States
Registry updated: 2024-09-25

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RecruitingNCT06378229

Psilocybin-assisted Psychotherapy in the Treatment of Patients Hospitalized for Treatment-resistant Depression: an Open-label Feasibility Study with an Experiential and Systemic Focus

Conditions: Treatment Resistant Depression
Phase: Phase 2
Enrollment: 100 estimated
Locations: Ghent University Hospital, Ghent, Oost-Vlaanderen, Belgium
Registry updated: 2024-09-19

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Unknown statusNCT05646303

A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

Conditions: Alcohol Use Disorder
Phase: Phase 2
Enrollment: 128 estimated
Locations: Sabi Mind, Calgary, Alberta, Canada · Okanagan Clinical Trials, Kelowna, British Columbia, Canada · Centre for Neurology Studies, Surrey, British Columbia, Canada · +9 more
Registry updated: 2024-08-15

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Active, not recruitingNCT04433858

An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

Conditions: Treatment Resistant Depression
Phase: Phase 2
Enrollment: 27 actual
Locations: VA Palo Alto Healthcare System/Stanford Medicine, Palo Alto, California, United States · Sheppard Pratt Health System, Baltimore, Maryland, United States
Registry updated: 2024-08-09

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RecruitingNCT06160232

Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Feasibility, Clinical Efficacy & (Neuro)Cognitive Mechanisms

Conditions: Severe Alcohol Use Disorder
Phase: Phase 2
Enrollment: 62 estimated
Locations: Brugmann University Hospital, Brussels, Belgium
Registry updated: 2024-08-07

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WithdrawnNCT05675800

Psilocybin for the Treatment of Major Depressive Disorder

Conditions: Major Depressive Disorder
Phase: Phase 2
Enrollment: 0 actual
Locations: No mapped site reported
Registry updated: 2024-07-25

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Unknown statusNCT04718792

Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

Conditions: Alcohol Use Disorder (AUD)
Phase: Phase 2
Enrollment: 10 actual
Locations: Psychiatric Center Copenhagen, Copenhagen, Frederiksberg, Denmark
Registry updated: 2024-07-12

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Unknown statusNCT06471959

Assessing the Feasibility of a Custom Psychedelic-assisted Group Program on Mental and Physical Health in First Responders

Conditions: Psilocybin · Psychotherapy, Group
Phase: Phase 1 · Phase 2
Enrollment: 32 estimated
Locations: Centre for Neurology Studies, Surrey, British Columbia, Canada
Registry updated: 2024-06-24

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CompletedNCT04505189

Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study

Conditions: Anorexia Nervosa
Phase: Phase 1 · Phase 2
Enrollment: 21 actual
Locations: Imperial College Hammersmith campus, London, United Kingdom
Registry updated: 2024-06-17

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Unknown statusNCT06444243

A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder

Conditions: Alcohol Use Disorder · Alcohol Dependence · Depression · Anxiety
Phase: Phase 2
Enrollment: 90 estimated
Locations: No mapped site reported
Registry updated: 2024-06-10

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SuspendedNCT05832255

An Open-Label Investigation of the Effects of Sub-Perceptual Repeat Dosing of Psilocybin on the Behavioural and Cognitive Symptoms of Fragile X Syndrome in Adult Patients

Conditions: Fragile X Syndrome · Behavior · Cognitive Dysfunction
Phase: Phase 2
Enrollment: 10 estimated
Locations: KGK Science Inc., London, Ontario, Canada
Registry updated: 2024-05-08

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RecruitingNCT05995769

Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial

Conditions: Alcohol Use Disorder · Alcoholism
Phase: Phase 2
Enrollment: 128 estimated
Locations: University of Calgary, Calgary, Alberta, Canada
Registry updated: 2024-05-07

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CompletedNCT04630964

The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density - A Single Dose Randomized, Double Blind, Placebo- Controlled Phase 2 Positron Emission Tomography Study

Conditions: Major Depressive Disorder · Depression
Phase: Phase 2
Enrollment: 35 actual
Locations: Northern Stockholm Spychiatry Clinic, Stockholm, Sweden
Registry updated: 2024-04-19

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WithdrawnNCT05242029

A Randomized, Double-Blind Study of Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use

Conditions: Opioid Use Disorder
Phase: Phase 2
Enrollment: 0 actual
Locations: No mapped site reported
Registry updated: 2024-02-02

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WithdrawnNCT05381974

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD

Conditions: Treatment-Resistant Major Depressive Disorder
Phase: Phase 2
Enrollment: 0 actual
Locations: Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, Massachusetts, United States
Registry updated: 2024-01-24

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WithdrawnNCT00979693

Psilocybin-assisted Psychotherapy in the Management of Anxiety Associated With Stage IV Melanoma.

Conditions: Anxiety · Stage IV Melanoma
Phase: Phase 2
Enrollment: 0 actual
Locations: Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Registry updated: 2023-12-26

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Unknown statusNCT06141876

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of Psilocybin-Assisted Psychotherapy in Treating Severe Depression Among Adults With Post-Traumatic Stress Disorder (PTSD).

Conditions: Post-traumatic Stress Disorder · Depression
Phase: Phase 2
Enrollment: 160 estimated
Locations: No mapped site reported
Registry updated: 2023-11-29

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CompletedNCT04739865

The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression

Conditions: Treatment Resistant Depression
Phase: Phase 2
Enrollment: 19 actual
Locations: Kadima Neuropsychiatry Institute, La Jolla, California, United States · Sheaf House, Tallaght Hospital, Dublin, Ireland
Registry updated: 2023-11-09

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CompletedNCT01534494

Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

Conditions: Alcohol Dependence
Phase: Phase 2
Enrollment: 10 actual
Locations: University of New Mexico Health Sciences Center, Albuquerque, New Mexico, United States
Registry updated: 2023-09-26

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CompletedNCT04141501

Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy and Mechanism in Alcohol Use Disorder

Conditions: Alcohol Use Disorder
Phase: Phase 2
Enrollment: 37 actual
Locations: Psychiatrische Universitätsklinik Zürich, Zurich, Switzerland
Registry updated: 2023-09-21

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CompletedNCT05029466

The Efficacy and Tolerability of Psilocybin in Participants With Treatment-Resistant Depression: a Phase 2, Randomized Feasibility Study

Conditions: Treatment Resistant Depression
Phase: Phase 2
Enrollment: 30 actual
Locations: Canadian Rapid Treatment Centre of Excellence (CRTCE), Mississauga, Ontario, Canada
Registry updated: 2023-07-27

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WithdrawnNCT05594667

Evaluating the Effect of Length of Time on Selective Serotonin Reuptake Inhibitors (SSRIs) on the Response to Psilocybin-assisted Therapy in Individuals With Mild-moderate Major Depressive Disorder (MDD)

Conditions: Depression · Major Depressive Disorder · Mild Depression · Moderate Depression
Phase: Phase 2
Enrollment: 0 actual
Locations: Centre for Neurology Studies x Upstream, Abbotsford British Columbia, British Columbia, Canada
Registry updated: 2023-07-06

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Unknown statusNCT05243329

Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder

Conditions: Treatment Resistant Disorders · Post Traumatic Stress Disorder
Phase: Phase 2
Enrollment: 20 estimated
Locations: Halucenex Life Sciences Inc., Windsor, Nova Scotia, Canada
Registry updated: 2023-06-29

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Unknown statusNCT05876481

Evaluation of the Acceptability, Safety, Feasibility, and Efficacy of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans

Conditions: PTSD
Phase: Phase 2
Enrollment: 8 estimated
Locations: Combat Stress, Leatherhead, Surrey, United Kingdom
Registry updated: 2023-05-25

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CompletedNCT03775200

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

Conditions: Treatment Resistant Depression
Phase: Phase 2
Enrollment: 233 actual
Locations: Kadima Neuropsychiatry Institute, La Jolla, California, United States · Altman Clinical and Translational Research Institute, University of California, San Diego, California, United States · Stanford Department of Psychiatry, Stanford, California, United States · +22 more
Registry updated: 2023-04-24

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CompletedNCT04656301

Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Conditions: Body Dysmorphic Disorders
Phase: Phase 2
Enrollment: 12 actual
Locations: New York State Psychiatric Institute, 1051 Riverside Drive, New York, New York, United States
Registry updated: 2023-03-13

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WithdrawnNCT05601648

SV2A Marker of Synaptogenesis in a Clinical Trial of Psilocybin for Depression

Conditions: Major Depressive Disorder · Anhedonia
Phase: Phase 2
Enrollment: 0 actual
Locations: Washington University School of Medicine, St Louis, Missouri, United States
Registry updated: 2023-01-30

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Active, not recruitingNCT04410913

Pilot Trial of Visual Healing®, a Nature-themed Virtual Immersive Experience, to Optimize Set and Setting in Psilocybin-assisted Therapy for Alcohol Use Disorder

Conditions: Alcohol Use Disorder
Phase: Phase 2
Enrollment: 20 actual
Locations: Pacific Treatment & Research in Psychedelics, Santa Monica, California, United States
Registry updated: 2023-01-17

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CompletedNCT02061293

A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence

Conditions: Alcohol Dependence
Phase: Phase 2
Enrollment: 95 actual
Locations: University of New Mexico Health Sciences Center, Albuquerque, New Mexico, United States · Clinical and Translational Science Institute, NYU Langone Medical Center, New York, New York, United States
Registry updated: 2022-11-08

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Unknown statusNCT04433845

The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

Conditions: Treatment Resistant Depression
Phase: Phase 2
Enrollment: 15 actual
Locations: Sheppard Pratt, Baltimore, Maryland, United States
Registry updated: 2022-10-25

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TerminatedNCT04280055

Prophylactic Effects of Psilocybin on Chronic Cluster Headache: an Open-label Clinical Trial and Neuroimaging Study

Conditions: Cluster Headache
Phase: Phase 1 · Phase 2
Enrollment: 10 actual
Locations: Neurobiology Research Unit, Rigshospitalet, Copenhagen, Denmark
Registry updated: 2022-08-10

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CompletedNCT04661514

Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy

Conditions: Anorexia Nervosa
Phase: Phase 2
Enrollment: 16 actual
Locations: Altman Clinical and Translational Research Institute, La Jolla, California, United States
Registry updated: 2022-07-25

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WithdrawnNCT04989972

Randomized Double Blind Placebo Controlled Assessing the Efficacy of Micro-dosed Psilocybin in Reducing Anxiety and or Depression Levels in Adults

Conditions: Anxiety and Depression
Phase: Phase 2
Enrollment: 0 actual
Locations: FMS Department of Psychiatry, Kingston, Jamaica
Registry updated: 2022-06-30

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Unknown statusNCT05383313

Psilocybin Versus Ketamine - Fast Acting Antidepressant Strategies in Treatment-resistant Depression

Conditions: Treatment Resistant Depression
Phase: Phase 2
Enrollment: 60 estimated
Locations: National Institute of Mental Health, Klecany, Czechia
Registry updated: 2022-05-20

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CompletedNCT03715127

Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy in Major Depression

Conditions: Depressive Disorder, Major
Phase: Phase 2
Enrollment: 55 actual
Locations: Psychiatrische Universitätsklinik Zürich, Zurich, Switzerland
Registry updated: 2022-04-29

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CompletedNCT03153579

LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders: a Randomized, Double-blind, Placebo-controlled Phase II Study

Conditions: Patients · Anxiety Disorders
Phase: Phase 2
Enrollment: 46 actual
Locations: University Hospital Basel, Basel, Canton of Basel-City, Switzerland · Private Practice P.Gasser, Solothurn, Canton of Solothurn, Switzerland
Registry updated: 2021-12-22

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CompletedNCT03181529

Effects of Psilocybin in Major Depressive Disorder

Conditions: Major Depressive Disorder
Phase: Phase 2
Enrollment: 27 actual
Locations: Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States
Registry updated: 2021-12-15

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Unknown statusNCT04593563

The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder

Conditions: Major Depressive Disorder
Phase: Phase 2
Enrollment: 30 actual
Locations: Maryland Oncology Hematology PA, Rockville, Maryland, United States
Registry updated: 2021-10-15

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Unknown statusNCT04959253

A Randomised, Placebo Controlled Trial of Psilocybin in Treatment Resistant Depression: A Feasibility Study

Conditions: Treatment Resistant Depression
Phase: Phase 2
Enrollment: 60 estimated
Locations: Clinical Research Facility, King's College Hospital, London, United Kingdom
Registry updated: 2021-07-22

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CompletedNCT02971605

Measurement of Persisting Changes in Emotional Brain Functioning Produced by Psilocybin

Conditions: Healthy
Phase: Phase 1 · Phase 2
Enrollment: 13 actual
Locations: Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States
Registry updated: 2019-09-10

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CompletedNCT00465595

Psychopharmacology of Psilocybin in Cancer Patients

Conditions: Depressive Symptoms · Anxiety · Cancer
Phase: Phase 2
Enrollment: 56 actual
Locations: Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Campus, Baltimore, Maryland, United States
Registry updated: 2018-07-19

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Unknown statusNCT03380442

Psilocybin and Depression - Assessing the Long-term Effects of a Single Administration of Psilocybin on the Psychiatric Symptoms and Brain Activity of Patients With Severe Depression

Conditions: Severe Depression
Phase: Phase 2
Enrollment: 60 estimated
Locations: No mapped site reported
Registry updated: 2017-12-21

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Phase 2 Psilocybin Clinical Trials

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150 matching registry records

Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin (NECTAR) in Aging and Alzheimer's Disease

Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder

The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease

An Exploratory Study of Feasibility, Efficacy, and Mechanisms of Mindfulness-Assisted Psychedelic Therapy

Feasibility Phase 2 Study of Psilocybin-Assisted Therapy for Opioid-Refractory Pain in Patients With Advanced Cancer

Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

A Phase 2a Study of Group Retreat Psilocybin Therapy for Cancer-Related Anxiety and Depression

Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)

Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND): An Open-Label Clinical Trial

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

Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression: A Pilot Randomized Clinical Trial

TRIP - TReatment to Improve Depression and/or Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors

NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy

Effects of Psilocybin on Electrophysiology and the Dynamic Content of Thought

A Randomized, Double-Blind, Placebo-Controlled Mechanistic Study to Assess a Single Oral Dose of CYB003 in Participants With Major Depressive Disorder (MDD) and Moderate to Severe Anxiety

PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Psilocybin-Assisted Therapy for Physician Well-Being and Burnout: Feasibility, Safety, Clinical Effectiveness and Biomarkers of Response [PAT-B (Psilocybin-Assisted Therapy for Physician Well-Being and Burnout)]

The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease

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

Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes

PSilocybin for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site, Open-label, Single Arm Phase I/II Proof-of-concept, Dose-finding, and Feasibility Clinical Trial

Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: A Randomized Phase II Clinical Trial Comparing One Versus Two Psychedelic Doses of Psilocybin (PSI-1V2)

Psilocybin: Capturing Brain Mechanisms of Motivation and Neurocognition in Individuals With Opioid Use Disorder

A Phase 2, Open-Label Study Investigating the Safety and Efficacy of Psilocybin-Assisted Therapy for Sexual Assault-Related Posttraumatic Stress Disorder (PTSD)

5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder

Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: An Open-label Trial

A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (PTSD)

Psilocybin-assisted Existential, Attachment and Relational (PEARL) Therapy for Caregivers of Patients With Advanced Cancer: A Phase II Open-Label Trial

Low-Dose Psilocybin Therapy for Palliative Care Patients With Chronic Cancer Pain Requiring Opioids

Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer: A Phase II Open-Label Trial

The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function

Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder: A Double-Blind, Dose-Comparison Concurrent Control Randomized Trial

2 x 2 Factorial, Double-blind, Randomized Trial of 'Set and Setting': a Translational Study in Healthy Volunteers

The Role of the Subjective Experience in Supporting Positive Effects Following Psilocybin: a Randomized, Controlled Clinical Trial Using Risperidone in Healthy Adults

The Safety and Acceptability of Psilocybin With Support and With Massed Prolonged Exposure Therapy for PTSD

Effects of Psilocybin With Psychological Support on Anhedonia in Treatment-resistant Depression: a Randomized Controlled Pilot Trial

A Pilot Mechanistic Study of Psilocybin-Assisted Therapy as a Treatment for Depression

Psilocybin-facilitated Treatment for Cocaine Use

Exploring the Safety, Acceptability, and Efficacy of Psilocybin Among Non-Small Cell Lung Cancer Patients With Major Depressive Disorder: A Proof-of-Concept Trial (DREAM LUNG STUDY)

Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence

Psilocybin for Treatment of Obsessive Compulsive Disorder

A Phase 2b/3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

The Safety and Efficacy of Psilocybin Therapy Compared to Low-dose Control in Reducing Depressive Symptoms in Patients With COPD, ALS, MS, or APD.

Does Psilocybin Require Psychedelic Effects to Treat Depression? A 4-Week, Double-Blind, Proof-of-Concept Randomized Controlled Trial

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer

A Phase 2 Randomized Study Examining the Safety, Feasibility, and Effectiveness of Masking Psilocybin Therapy With General Anesthesia in Major Depressive Disorder

A Phase 2 Sequential Dose-Finding Study of Preparation for Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression

Safety, Tolerability, Outcomes of Psilocybin for Depression (STOP Depression) in Veterans With Spinal Cord Injury

Group Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder

Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)

A Double-blind, Randomized Trial Examining the Preliminary Efficacy of Psilocybin Therapy for People With Chronic Low Back Pain

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

A Randomized, Double-Blind Study of Single-Dose Psilocybin for Major Depressive Disorder (MDD)

Toward Patient-Tailored Care for Treatment-Resistant Depression: A Pilot Patient-Preference Clinical Trial of Music and Mindfulness in Psilocybin-Assisted Psychotherapy

CAPSI - Cancer Related Major Depression Treated With a Single Dose of Psilocybin: A Multicenter Randomized Placebo Controlled Double Blind Clinical Trial

Engaging Mood Brain Circuits With Psilocybin: a Randomized Neuroimaging Trial in Depression

Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder

Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression

The QUANTUM Trip Trial - Psilocybin-assisted Therapy for Reducing Alcohol Intake in Patients With Alcohol Use Disorder: A Randomized, Double-blinded, Placebo-controlled Clinical Trial.

Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder

The Therapeutic Potential of Psilocybin in Anorexia Nervosa in Young Adults

Examining the Safety and Clinical Efficacy of Psilocybin Therapy for Veterans With PTSD: An Open-Label Proof-of-Concept Trial

A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.

Study of Psilocybin for Anorexia in Young Adults

Does Psilocybin Change Synaptic Density in the Brains of Patients With Amnestic Mild Cognitive Impairment

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

Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care - PATH Study

Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder: A Pilot Randomized Clinical Trial

Psilocybin-Assisted Cognitive Behavioral Therapy for Depression

A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Oral Psilocybin (TRP-8802) Administration in Concert With Psychotherapy Among Adult Patients With Irritable Bowel Syndrome: A Randomized Delayed Treatment Control Design

Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER: a Pilot Study