- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06814522
Psilocybin-Assisted Therapy for Physician Well-Being and Burnout (PAT-B)
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 Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Jessie Kim
- Phone Number: 619-494-0037
- Email: jbk005@health.ucsd.edu
Study Contact Backup
- Name: Cory Weissman
- Email: cweissman@health.ucsd.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92037
- Recruiting
- UC San Diego
-
Contact:
- Jessie Kim
- Phone Number: 619-494-0037
- Email: jbk005@health.ucsd.edu
-
Principal Investigator:
- Cory R Weissman, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- UCSD 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
Exclusion Criteria:
- 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 10 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psilocybin-Assisted Therapy
Subjects will receive a single dose of psilocybin in conjunction with psychedelic-assisted therapy.
|
25 mg, single dose of psilocybin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment until end of study at 12 week follow-up.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 176596
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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