Clinical trial NCT06814522: Psilocybin-Assisted Therapy for Physician Well-Being and Burnout
Official 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)]
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Burnout
Burnout, Healthcare Workers
Keywords: burnout
physician
doctor
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. UCSD faculty physician, aged 21-70. Volunteer faculty are not included
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 nonpsychotropic medication that may be associated with serotonin syndrome, such as serotonin reuptake inhibitors (SSRI or SNRI), dextromethorphan, linezolid, tramadol, meperidine

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 (borderline personality disorder, antisocial personality disorder, or other severe personality disorders), any 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, 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 including history of stroke, myocardial infarction, uncontrolled hypertension, valvular heart disease, tachycardia, elongated QT interval, or clinically significant arrythmia.
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

Primary outcomes:
measure: Stanford Professional Fulfillment Index (PFI)
timeFrame: From enrollment until end of study at 12 week follow-up
Secondary outcomes:
Other outcomes:
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