Recruiting
Phase 1
Phase 2

PAT

Sponsor:

UCLA

Code:

NCT06814522

Conditions

Burnout

Burnout, Healthcare Workers

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

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

Real-time Biofeedback

Study Details

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.

Conditions

Burnout

Burnout, Healthcare Workers

Study ID

NCT06814522

Start date

Jan 13, 2025

Status verified date

Nov, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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 5 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psilocybin-Assisted Therapy with Biofeedback

Subjects will receive a single dose of psilocybin in conjunction with psychedelic-assisted therapy and real-time visual biofeedback available to the therapist during sessions.

active comparator: Psilocybin-Assisted Therapy without Biofeedback

Subjects will receive a single dose of psilocybin in conjunction with psychedelic-assisted therapy, without real-time visual biofeedback available to the therapist during sessions.

Interventions

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

25 mg, single dose of psilocybin

Real-time Biofeedback

Real-time visual biofeedback signal derived from multimodal dyadic synchrony measures (e.g., EEG, autonomic physiology, facial expression, speech) presented to the therapist during therapy sessions to inform delivery of psychotherapy.

Primary outcome measure

  • Stanford Professional Fulfillment Index (PFI) [ Time Frame: From enrollment until end of study at 12 week follow-up. ]

Central Contacts and Locations

Locations

UC San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Principal Investigator:

Cory R Weissman, MD, PhD

More Information

Sponsor

University of California, San Diego

Last update posted

Sep 2, 2026

Last verified

Nov, 2025

Keywords

  • burnout
  • physician
  • doctor
  • psilocybin
  • biofeedback
  • electroencephalography
  • psychotherapy
  • synchrony
  • professional fulfillment
  • dyadic
  • neurofeedback

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-09-02.