Frontline Clinician Psilocybin Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-03

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to investigate the effects of a single dose of psilocybin, delivered in the contextof pre- and post-dose psychotherapy, on symptoms of depression and burnout suffered by healthcare clinicians as a result of frontline work in the COVID pandemic.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Psilocybin-assisted Interpersonal Therapy for Depression

NCT05581797

Depressive Disorder, Treatment-Resistant

COMPLETED NA

Psilocybin-assisted CBT for Depression

NCT05227612

Major Depressive Disorder

COMPLETED PHASE1

RCT of Psilocybin-assisted CBT for Depression

NCT07281352

Major Depressive Diorder

RECRUITING PHASE1/PHASE2

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

NCT04982796

Amphetamine-Related Disorders

RECRUITING PHASE1/PHASE2

Psilocybin and Spiritual Practice

NCT00802282

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Aim 1:

To assess short- and longer-term effects of psilocybin-assisted psychotherapy (PAP) on symptoms of depression experienced by physicians and nurses with frontline work exposure in the COVID pandemic.

Hypothesis 1.1: Compared to active placebo, PAP will result in short term improvement in symptoms of depression 1 day and 1 week after the psilocybin dose session. Hypothesis 1.2: Compared to active placebo, PAP will result in longer term improvement of symptoms of depression 4 weeks after the medication dosing session. The primary outcome will be a comparison between the psilocybin 25 mg vs control groups of a combination of depression symptoms measured at 4 weeks post medication dose session. 1.1.2. Aim 2: To explore short- and longer-term effects of psilocybin-assisted psychotherapy (PAP) on symptoms of burnout experienced by physicians and nurses with frontline work exposure in the COVID pandemic. Hypothesis 2.1: Compared to active placebo, PAP will result in short term improvement in symptoms of burnout 1 day and 1 week after the psilocybin dose session.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burnout, Caregiver Burnout, Professional COVID-19 Depression Post Traumatic Stress Disorder Moral Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study tests a hypothesis that a single session of psilocybin (the 'medication dosing' session) in the context of pre- and post-dose psychotherapy will result in improvement of symptoms of depression and burnout measured 4 weeks post-dose. This study hypothesis will be tested in a single site, double-blind, randomized controlled design involving 30 clinician participants that will compare effects of a single 25mg oral dose of psilocybin to a 250 mg of niacin (active placebo). The primary outcome measurements will be collected 4 weeks after the psilocybin dose, after which the participant group assignment will be unblinded, and participants who received niacin will be offered the opportunity to have a second dose session with a 25 mg dose (with pre- and post-dose psychotherapy).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The investigators, study therapists, and outcomes assessors will all be blinded in the randomized phase of the study. Participants will be unblinded after the primary outcome, and those receiving placebo will be eligible to receive open label psilocybin.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Psilocybin arm

psychedelic assisted psychotherapy + 25mg psilocybin

Group Type EXPERIMENTAL

Psilocybin (Usona Institute)

Intervention Type DRUG

PAP + psilocybin 25 mg

Placebo

Psychedelic assisted psychotherapy + 250mg niacin

Group Type ACTIVE_COMPARATOR

Active placebo

Intervention Type DRUG

PAP + niacin 250mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psilocybin (Usona Institute)

PAP + psilocybin 25 mg

Intervention Type DRUG

Active placebo

PAP + niacin 250mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Psychedelic-assisted psychotherapy (PAP) PAP with placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participants must be physicians or nurses with at least 1 month of frontline clinical experience during the COVID pandemic who rate at least 2 of 4 items from the COVID Exposure index as 'more than half the days' during their peak 2 week period of exposure: i. Caring for someone critically ill with COVID-19, or who became critically ill while you were involved; ii. Working longer hours than usual in order to provide assistance or care to individuals with COVID-19; iii. Witnessing or responding to a death related to COVID-19, or losing a patient you had been caring for to COVID-19; iv. Caring for patients who have died without family physically present due to COVID-19 precautions
2. Have a Montgomery-Asberg Depression Rating Scale (MADRS) clinician-administered depression score \>21, indicating moderately severe symptoms.
3. Have had persistent symptoms despite at least one medication and/or therapy trial of standard care treatment for depression.
4. English speaking - able to understand the process of consent and the risk and benefits associated with the study, and able to give written informed consent.
5. Must be willing to sign a medical release for the investigators to communicate directly with their therapist and doctors to confirm a medication and/or medical history. This is decided on a case-by-case basis upon the discretion of the PI.
6. Must be driven home after the medication dosing session by a driver (which could be a friend, family, rideshare or taxi).
7. Must provide at least one adult to have continuous contact with the participant, provide participant transportation, monitor changes in the participant's behavior, and notify research staff of behavior changes.
8. Has been off selective serotonin inhibitors (SSRIs) for at least five half-lives of the drug plus 2 weeks.
9. Must avoid taking any psychiatric medications or starting a new psychiatric medication during the study. Should participant's doctor recommend starting a new psychiatric medication, participant will be required to notify the study team and the subject would withdraw from the study
10. 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.
11. If able to bear children, must have a negative pregnancy test at study entry.
12. Are willing to commit to preparation sessions, medication dosing sessions, integration sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts.

Exclusion Criteria

1. Personal or immediate family history of schizophrenia, bipolar affective disorder, delusion disorder, paranoid disorder, or schizoaffective disorder.
2. Suicidal ideation with a Columbia Suicide Severity Rating Scale (C-SSRS) \> 3
3. Current substance abuse disorder (except in the case of mild alcohol use )
4. Neuroleptic and SSRI medications that cannot be tapered and discontinued in conjunction with the participant's prescribing physician.
5. Unstable neurological or medical condition; history of seizure, chronic/severe headaches.
6. Positive urine pregnancy test at the time of screening
7. Any unstable medical condition that my render study procedures unsafe.
8. Any use of psychedelic drugs within the prior 12 months.
9. Use of tramadol, due to the potential for serotonin syndrome with concomitant use of psilocybin.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No