RecruitingPhase 1Phase 2NCT06814522
Psilocybin-Assisted Therapy for Physician Well-Being and Burnout
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)]
Sponsor
University of California, San Diego
Enrollment
10 participants
Start Date
Jan 13, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 21 YearsMax Age: 70 Years
Inclusion Criteria6
- 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 Criteria12
- 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
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Interventions
DRUGPsilocybin, [3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate
25 mg, single dose of psilocybin
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06814522
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