BurnoutPhase 1/2PAT-BNCT06814522
Psilocybin-Assisted Therapy for Physician Well-Being and Burnout
A Phase 1/2 study testing Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate and Real-time Biofeedback in people with Burnout and Burnout, Healthcare Workers, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Burnout, Burnout, Healthcare Workers
- What is being tested?
- Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate and Real-time Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cory Weissman contact
United States1 site, 1 recruiting
- Recruiting
UC San Diego
San Diego, California, 92037
Vy Nguyen, 619-363-2465, vyn014@health.ucsd.edu
Cory R Weissman, MD, PhD
About this study
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)]
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.
Read the 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 is to assess whether incorporating biofeedback of interpersonal synchrony and individual biosignal biofeedback measures can enhance PAT outcomes. This will be determined by the superiority in the reduction of pre- and post-treatment burnout subscale scores of the biofeedback arm compared to the standard PAT arm. The secondary aim is to confirm the safety, tolerability, and efficacy of PAT to reduce burnout symptoms in physicians. In addition to these aims, exploratory analyses will examine neurophysiological and behavioral measures (e.g., EEG and multimodal synchrony) to evaluate their associations with clinical outcomes and identify potential biomarkers of response to psilocybin-assisted therapy.
- Conditions
- Burnout, Burnout, Healthcare Workers
- Being tested
- Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate, Real-time Biofeedback
- Keywords
- burnout, physician, doctor, psilocybin, biofeedback, electroencephalography, psychotherapy, synchrony, professional fulfillment, dyadic, neurofeedback
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphateDrug
Also called Psilocybin
25 mg, single dose of psilocybin
Real-time BiofeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stanford Professional Fulfillment Index (PFI)
Assessment used to determine degree/severity of burnout.
Measured: From enrollment until end of study at 12 week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start13 Jan 2025
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Research Projects Agency for Health (ARPA-H)
- Responsible party
- Principal investigator, Cory Weissman, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814522
- Sponsor's protocol ID
- 176596
- Acronym
- PAT-B
- Status last verified
- Nov 2025
- First submitted
- 1 Feb 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)]
- ClinicalTrials.gov ID
- NCT06814522
- Acronym / sponsor ID
- PAT-B / 176596
- Conditions
- Burnout, Burnout, Healthcare Workers
- Keywords
- burnout, physician, doctor, psilocybin, biofeedback, electroencephalography, psychotherapy, synchrony
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Advanced Research Projects Agency for Health (ARPA-H)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 is to assess whether incorporating biofeedback of interpersonal synchrony and individual biosignal biofeedback measures can enhance PAT outcomes. This will be determined by the superiority in the reduction of pre- and post-treatment burnout subscale scores of the biofeedback arm compared to the standard PAT arm. The secondary aim is to confirm the safety, tolerability, and efficacy of PAT to reduce burnout symptoms in physicians. In addition to these aims, exploratory analyses will examine neurophysiological and behavioral measures (e.g., EEG and multimodal synchrony) to evaluate their associations with clinical outcomes and identify potential biomarkers of response to psilocybin-assisted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin-Assisted Therapy with Biofeedback | Experimental | Drug: Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate, Device: Real-time BiofeedbackSubjects will receive a single dose of psilocybin in conjunction with psychedelic-assisted therapy and real-time visual biofeedback available to the therapist during sessions. |
| Psilocybin-Assisted Therapy without Biofeedback | Active comparator | Drug: Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphateSubjects will receive a single dose of psilocybin in conjunction with psychedelic-assisted therapy, without real-time visual biofeedback available to the therapist during sessions. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphateAlso: Psilocybin25 mg, single dose of psilocybin | Drug | Psilocybin-Assisted Therapy with Biofeedback, Psilocybin-Assisted Therapy without Biofeedback |
| Real-time BiofeedbackReal-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. | Device | Psilocybin-Assisted Therapy with Biofeedback |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cory Weissman contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate and Real-time Biofeedback in people with Burnout and Burnout, Healthcare Workers, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vy Nguyen (619-363-2465, vyn014@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stanford Professional Fulfillment Index (PFI) (time frame: From enrollment until end of study at 12 week follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.