Psilocybin-Assisted Therapy for Physician Well-Being and Burnout

NCT06814522 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 176596
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Stanford Professional Fulfillment Index (PFI)

  Assessment used to determine degree/severity of burnout.

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

Study Arms (2)

Psilocybin-Assisted Therapy with Biofeedback

EXPERIMENTAL

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.

Drug: Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate; Device: Real-time Biofeedback

Psilocybin-Assisted Therapy without Biofeedback

ACTIVE COMPARATOR

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.

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

Interventions

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

25 mg, single dose of psilocybin

Also known as: Psilocybin

Psilocybin-Assisted Therapy with Biofeedback; Psilocybin-Assisted Therapy without Biofeedback

Real-time Biofeedback DEVICE

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.

Psilocybin-Assisted Therapy with Biofeedback

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 5 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Advanced Research Projects Agency for Health (ARPA-H): collaborator

Study Sites (1)

UC San Diego

San Diego, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Central Study Contacts

Vy Nguyen

CONTACT

619-363-2465; vyn014@health.ucsd.edu

Cory Weissman

CONTACT

cweissman@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Cory Weissman

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 7, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)