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Psychedelic
Psilocybin Therapy for Clinician Burnout and Depression
Phase 3
Waitlist Available
Led By Anthony Back, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy
Awards & highlights
Study Summary
This trial will investigate whether psilocybin, given with therapy, can help reduce depression and burnout in healthcare clinicians caused by their work during the COVID pandemic.
Who is the study for?
This trial is for English-speaking physicians and nurses who have faced significant stress from frontline work during the COVID pandemic, with moderate to severe depression symptoms. They must not be on SSRIs or start new psychiatric meds during the study, need a negative pregnancy test if applicable, and commit to all sessions and evaluations. A support person must be available for transportation and monitoring post-dosing.Check my eligibility
What is being tested?
The study tests the impact of a single dose of psilocybin combined with psychotherapy on healthcare workers' depression and burnout due to COVID-19 related stress. Participants will also receive pre- and post-dose therapy sessions to help integrate their experiences.See study design
What are the potential side effects?
Potential side effects include temporary changes in perception, mood swings, dizziness, nausea, intensified emotions or memories during treatment. Long-term side effects are unknown but could involve persistent alterations in mood or thought patterns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Mental Depression
Mental Depression
Moral injury symptom scale
+2 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Hypoesthesia
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Psilocybin armExperimental Treatment1 Intervention
psychedelic assisted psychotherapy + 25mg psilocybin
Group II: PlaceboActive Control1 Intervention
Psychedelic assisted psychotherapy + 250mg niacin
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,743 Previous Clinical Trials
1,847,840 Total Patients Enrolled
Anthony Back, MDPrincipal InvestigatorUniversity of Washington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a score of 21 or more on the MADRS clinician-administered depression scale.You must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal.I am willing to attend all sessions, take medications, and complete evaluations as required.I am not taking tramadol due to its risks with psilocybin.I have an adult who can support me during the trial, including transportation and monitoring my health.My depression symptoms persist despite trying at least one standard treatment.I stopped taking SSRIs over 2 weeks ago, considering the drug's half-life.I have arranged for someone to drive me home after my medication session.I am not taking new psychiatric medications during the study.I am a healthcare worker who has directly cared for COVID-19 patients during the pandemic.I cannot stop taking my neuroleptic or SSRI medications.I do not have a history of seizures or chronic severe headaches.I can ensure an adult will support me throughout the study.I have arranged for someone to drive me home after my medication session.I stopped taking SSRIs at least 5 half-lives of the drug plus 2 weeks ago.My depression symptoms persist despite trying at least one standard treatment.You are able to understand the process of consent and the risk and benefits associated with the study, and able to give written informed consent.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin arm
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Burnout Patient Testimony for trial: Trial Name: NCT05163496 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants will be accepted to this experiment?
"Affirmative, according to records on clinicaltrials.gov this trial is still searching for participants who meet the criteria. It was first posted in March 3rd 2022 and its last update being July 13th 2022. 30 individuals are needed at a single site location."
Answered by AI
Has the Usona Institute conducted any other research involving psilocybin?
"Currently, Usona Institute is conducting 33 live trials on Psilocybin with none of them in Phase 3. Though the majority are located in Vancouver, Washington, a total of 36 sites across North America have studies regarding this substance running."
Answered by AI
Are there still available slots for enrollment in this clinical trial?
"Affirmative. Information accessible on clinicaltrials.gov attests to the fact that this medical trial, established on March 3rd 2022, is actively recruiting participants. Approximately 30 individuals are required at one location in order for the study to be completed successfully."
Answered by AI
Who else is applying?
What state do they live in?
Oregon
California
Washington
Other
How old are they?
65+
18 - 65
What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
What questions have other patients asked about this trial?
How often would I need to travel up to Seattle? I’m also currently on medication - Lamotrigine, Duloxetine, and Adderall. Is that a problem?
PatientReceived no prior treatments
Why did patients apply to this trial?
Interested in potential therapeutic effects in regard to burnout. I’ve tried several meds, ideologies, etc to address burnout and depression with little to no help.
PatientReceived no prior treatments
I’ve been wanting to try something like this after dealing with depression on and off throughout my life. I’ve tried many different medications and I would like to try something more natural and with ritual behind it.
PatientReceived 2+ prior treatments
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