Clinical TrialImplementation & Service DeliveryPsilocybinRecruiting

Psilocybin-Assisted Therapy for Physician Well-Being and Burnout

Open-label single-group study (n=10) assessing feasibility, safety, and preliminary efficacy of a single 25 mg oral psilocybin dose with preparatory and integration therapy for UCSD physicians with burnout.

Target Enrollment
10 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

This open-label feasibility study will enrol ten University of California, San Diego physicians experiencing persistent burnout to evaluate safety, tolerability, and preliminary clinical response to psilocybin-assisted therapy (PAT). Participants will receive preparatory psychological sessions, a single 25 mg oral dose of synthetic psilocybin, and post-dosing integration sessions.

Outcomes include feasibility and safety measures, change in burnout measured with the Stanford Professional Fulfillment Index, and exploratory neurophysiological assessments to identify brain changes associated with treatment response.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin-Assisted Therapy

experimental

Single-group open-label administration of a 25 mg oral synthetic psilocybin dose combined with preparatory and integration therapy.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Synthetic psilocybin, single 25 mg dose with psychological support.

Participants

Ages
21 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. UCSD faculty physician, aged 21-70.
  • 2. Meets criteria for physician burnout.
  • 3. Experiencing symptoms of burnout for >6 months.
  • 4. Able to complete all required study visits.
  • 5. Not previously diagnosed with a serious mental illness (including schizophrenia, bipolar disorder, and severe depression), or substance use disorder as confirmed in clinical interview.
  • 6. Not currently taking any psychotropic medications or non-psychotropic medication that may be associated with serotonin syndrome (e.g., SSRI/SNRI, dextromethorphan, linezolid, tramadol, meperidine).

Exclusion Criteria

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

Study Details

Locations

UC San Diego — San Diego, California, United States

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