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NCT Number: NCT06814522

Psilocybin-Assisted Therapy for Physician Well-Being and Burnout

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UC San Diego

San Diego, California, 92037, United States

Location status: Recruiting

Location contact

Cory R Weissman, MD, PhD

PRINCIPAL_INVESTIGATOR

Vy Nguyen

CONTACT

[email protected]

619-363-2465

About this study

Physician burnout is a critical issue. Research shows that physician burnout is increasing, that physicians suffer higher rates of burnout than the general population, and that physician burnout is associated with poor mental health outcomes.

Psilocybin is a naturally occurring alkaloid within certain fungi that elicits acute perceptual, cognitive, and emotional changes when ingested, due to action on neurotransmitter and neurocirculatory systems. The combination of psilocybin with psychological support, termed Psilocybin-Assisted Therapy (PAT), is a promising new mental health intervention shown to produce rapid and sustained improvements in psychological domains affected in burnout. PAT demonstrates preliminary efficacy as a treatment for depression and substance use disorders, is associated with brain changes measured with electroencephalography (EEG) and is a strong candidate treatment for physician burnout.

The primary aim of this study is to investigate the safety, feasibility, and preliminary efficacy of PAT to enhance well-being in University of California, San Diego (UCSD) physicians experiencing burnout. A secondary aim is to identify neurophysiological changes associated with response to PAT. Physicians experiencing burnout will be recruited in an open-label trial involving preparatory therapy sessions, psilocybin treatment, and post-treatment integration. Burnout will be measured with the Stanford Professional Fulfillment Index (PFI).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • UCSD faculty physician, aged 21-70. Volunteer faculty are not included
  • Meets criteria for physician burnout
  • Experiencing symptoms of burnout for >6 months
  • Able to complete all required study visits
  • Not previously diagnosed with a serious mental illness (including schizophrenia, bipolar disorder, and severe depression), or substance use disorder as confirmed in clinical interview
  • Not currently taking any psychotropic medications or nonpsychotropic medication that may be associated with serotonin syndrome, such as serotonin reuptake inhibitors (SSRI or SNRI), dextromethorphan, linezolid, tramadol, meperidine

Exclusion criteria

  • Previous inpatient psychiatric hospitalization(s)
  • Previously diagnosed with a psychotic disorder (schizophrenia, schizoaffective disorder, or other psychotic spectrum disorder), bipolar spectrum disorder, personality disorder (borderline personality disorder, antisocial personality disorder, or other severe personality disorders), any severe psychiatric disorder.
  • Exhibiting elevated suicide risk
  • First degree family history of psychosis or bipolar disorder
  • Prior exposure to psilocybin or other psychedelic compounds in the previous 10 years
  • Currently pregnant, nursing, planning pregnancy, engaging in sexual intercourse without effective contraceptive method in last three months
  • Those who plan to donate sperm within three months following the study.
  • Known cardiovascular disease including history of stroke, myocardial infarction, uncontrolled hypertension, valvular heart disease, tachycardia, elongated QT interval, or clinically significant arrythmia.
  • History of seizure disorder
  • Use of recreational illicit drugs
  • Clinically concerning results from vital signs, ECG, physical examination, or laboratory tests during screening
  • Any other clinically significant illnesses deemed to pose risk for the participant

Treatment and study plan

Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate

Drug

25 mg, single dose of psilocybin

Other names: Psilocybin

Primary outcomes

  1. Stanford Professional Fulfillment Index (PFI)

    Time frame: From enrollment until end of study at 12 week follow-up.

    Assessment used to determine degree/severity of burnout.

Study contacts

Contact information is provided by the study sponsor or research team.

Cory Weissman

CONTACT

[email protected]

Vy Nguyen

CONTACT

[email protected]

619-363-2465

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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)]

Acronym: PAT-B

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 7, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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