Not Yet RecruitingPhase 2psilocybin
Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression
Sponsored by University of Washington
NCT ID
NCT07565909
Target Enrollment
72 participants
Start Date
2026-06
Est. Completion
2028-07
About This Study
In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression and loss of meaning during the past 5 years. Each participant will be in a group cohort of 8, and 3 cohorts will be tested at each dose level. The objectives are safety, feasibility, mechanism testing, and outcomes.
Conditions Studied
Interventions
- •Psilocybin
Eligibility
Age:25 Years - 70 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: 1. Healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) currently in clinical practice 2. Age 25-70 years 3. Loss of meaning single question "I used to find deep meaning in my work as a healthcare clinician, but during the past 5 years that sense of meaning has faded". 4. PHQ-9 score ≥10 (moderate symptoms of depression) 5. Ability to commit to all preparation sessions and retreat attendance 6. English fluency sufficient for group participation 7. Screening laboratory tests within acceptable limits, including liver function tests 8. Negative urine drug screen for non-prescribed psychoactive medications. 9. ECG with QTc \<450 ms 10. Willing to taper and discontinue any supplements with serotonin-like properties, including but not limited to 5-HTP, St. John's Wort, and 'brain food' supplements. 11. For participants of childbearing potential, agree to use to use highly effective contraception. Highly effective contraceptive methods are defined as those that, alone or in combination, result in a low failure rate (less than 1 percent per year), including but not limited to implants, IUDs, contraceptive injections, or contraceptive pills. Exclusion Criteria: 1. Personal or first-degree family history of psychotic disorder or bipolar I disorder 2. Personal major depressive episode prior to entering healthcare as a professional 3. Active suicidal ideation with intent or plan 4. Unstable medical conditions 5. Pregnancy or breastfeeding 6. Hypertension with BP systolic \>150 or diastolic \> 90