Psilocybin-Assisted Therapy for Burnout

(PAT-B Trial)

Overseen By Cory Weissman

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, San Diego

Must not be taking: Psychotropics, SSRIs, SNRIs, others

Disqualifiers: Psychotic disorders, Bipolar, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether psilocybin, a compound found in certain mushrooms, can reduce burnout symptoms in doctors. It specifically targets UCSD physicians who have experienced burnout for more than six months. The goal is to determine the safety and effectiveness of this treatment when combined with therapy. Participants should not have a history of serious mental illness or be taking certain medications. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

Yes, you cannot participate if you are currently taking any psychotropic medications or certain other medications that may cause serotonin syndrome, like SSRIs or SNRIs.

Is there any evidence suggesting that psilocybin-assisted therapy is likely to be safe for humans?

Research has shown that psilocybin-assisted therapy is generally well-tolerated. Studies have found it can significantly improve symptoms of depression and burnout. Importantly, these studies reported no serious side effects, suggesting the treatment is safe for participants. However, as with any treatment, individual experiences may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for burnout, which often include lifestyle changes and cognitive behavioral therapy, psilocybin-assisted therapy introduces a novel approach by using a psychedelic compound. Psilocybin is unique because it targets the brain's serotonin receptors, potentially offering a profound shift in mood and perception with just a single dose. Researchers are excited about psilocybin because it may provide rapid and lasting relief from burnout symptoms, offering a transformative experience rather than just incremental improvement. This treatment could redefine how we understand and manage burnout, moving beyond traditional methods to address the condition more holistically.

What evidence suggests that psilocybin-assisted therapy might be an effective treatment for burnout?

Research has shown that therapy using psilocybin, a compound found in certain mushrooms, may help reduce burnout symptoms. In this trial, participants will receive Psilocybin-Assisted Therapy, which involves a single dose of psilocybin combined with psychedelic-assisted therapy. When used alongside mindfulness training, psilocybin can significantly ease feelings of depression and burnout. In one study, healthcare workers who received psilocybin therapy reported feeling less burned out and depressed. Another study with Emergency Medical Service Workers suggested that psilocybin experiences might help lower job-related burnout. These findings indicate that psilocybin could be a promising treatment for burnout. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for UCSD faculty physicians aged 21-70 who are experiencing burnout symptoms for more than 6 months. They must be able to attend all study visits and not have a history of serious mental illness or substance use disorder. Participants should not be on medications that could lead to serotonin syndrome.

Inclusion Criteria

I am experiencing symptoms of burnout.

I have felt burned out for more than 6 months.

I can attend all the study appointments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Therapy

Participants undergo preparatory therapy sessions before psilocybin treatment

2 weeks

Psilocybin Treatment

Participants receive a single dose of psilocybin in conjunction with psychedelic-assisted therapy

1 day

1 visit (in-person)

Post-treatment Integration

Participants engage in post-treatment integration sessions to process the experience

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The trial is exploring the use of Psilocybin-Assisted Therapy (PAT) as a potential treatment for physician burnout. It's an open-label study, meaning both researchers and participants know what treatment is being given, aimed at assessing its safety and initial effectiveness.

How Is the Trial Designed?

Group I: Psilocybin-Assisted Therapy Experimental Treatment 1 Intervention

Subjects will receive a single dose of psilocybin in conjunction with psychedelic-assisted therapy.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Citations

1. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004519

Psilocybin-assisted group psychotherapy and mindfulness ... These findings suggest that group psilocybin-assisted therapy, when combined with mindfulness training, may provide greater relief from depression and burnout ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40972137/

Psilocybin-assisted group psychotherapy and mindfulness ... Our findings suggest that integrating psilocybin with mindfulness training may represent a promising treatment for depression and burnout among ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827553

Psilocybin Therapy for Clinicians With Symptoms of ... This randomized clinical trial examines the effect of psylocibin on the level of depression, burnout, and posttraumatic stress disorder ...

4. akjournals.com akjournals.com/view/journals/2054/9/1/article-p20.xml

Change in occupational burnout measures in emergency ... This naturalistic mixed methods field study, aimed to assess the potential of a psilocybin induced experience, to help Emergency Medical Service Workers (EMSW)

5. medrxiv.org medrxiv.org/content/10.1101/2024.12.31.24319806v1.full-text

Psilocybin-Assisted Group Psychotherapy + Mindfulness ... Group psilocybin-assisted therapy plus MBSR was associated with clinically significant improvement in depressive symptoms without serious adverse events.