Psilocybin-Assisted Therapy for First Responders

Overseen By Jonathan Hill

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Empower Research Inc

Must not be taking: Anticonvulsants, MAOIs, Tricyclics, others

Disqualifiers: Schizophrenia, Bipolar, Substance abuse, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

32 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

Participants must have a stable dose of their current medications for the last three months and should not anticipate changes during the study. However, they must refrain from taking certain nonprescription medications, nutritional supplements, or herbal supplements for one week before the drug sessions, unless approved by the study Investigator.

What data supports the effectiveness of the drug psilocybin for first responders?

Research shows that psilocybin has been studied in clinical trials for various psychiatric disorders, including depression and anxiety, with some patients experiencing long-term improvements after just one or a few sessions. It has also shown promise in reducing symptoms of depression and anxiety in cancer-related psychological distress and has had encouraging success rates in treating alcohol and cigarette addiction. ^{1 2 3 4 5}

Is psilocybin generally safe for humans?

Psilocybin has been studied in healthy adults and is generally considered safe when used in controlled settings with proper support, although it can cause challenging psychological experiences and, in rare cases, lead to risky behavior or enduring psychological distress. ^{3 5 6 7 8}

How is the drug psilocybin unique compared to other treatments for first responders?

Psilocybin is unique because it is a psychedelic substance that can induce profound changes in perception and mood, potentially leading to long-term improvements after just one or a few sessions. Unlike many traditional treatments, it is being explored for its ability to help with psychiatric disorders and emotional challenges, even in cases where other treatments have failed. ^{1 3 4 9 10}

What is the purpose of this trial?

This study is a two-group feasibility study of oral psilocybin combined with a 12-week group-based program, customized for firefighters. Trained facilitators will help create a trauma-informed space for the group (n = 6-8) to thrive and promote cognitive resilience. The topics covered throughout the 12 weeks include breath-work, mindfulness, self-compassion, embodiment, and Internal Family Systems work. Group 1 (control): 12-week group-based program, with a breathwork day at week 10 Group 2 (intervention): 12-week group-based program, with a 10mg dose of psilocybin (PEX010) at Week 10 Assessment timepoints: * Baseline * Mid-program (Week 6) * End of program (Week 12) * 6-month follow up

Research Team

Reginald Peters, MD

Principal Investigator

University of British Columbia (Clinical Assistant Professor)

Eligibility Criteria

This trial is for firefighters who may benefit from a group program designed to promote cognitive resilience. Participants must be able to commit to a 12-week program and are willing to potentially receive psilocybin as part of the treatment.

Inclusion Criteria

Clinically diagnosed with a mental health condition such as: Depression, Chronic anxiety, Obsessive-compulsive disorder, PTSD, Unresolved grief, Adjustment Disorder, Acute Stress Disorder

Agree not to take any 'as needed' medications on the morning of the Week 10 visit

Agree to use of highly effective methods of contraception during the study (females)

Exclusion Criteria

Presence of active psychotic symptoms

Significantly intrusive PTSD as determined by the Investigator

Extreme emotional lability can be disruptive to the group milieu and is a relative exclusion criterion

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week, group-based program with weekly sessions, including a psilocybin dose or breathwork day at Week 10

12 weeks

1 in-person visit at start, 1 in-person visit at Week 10, remaining sessions remote

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person or remote) at 6-month follow-up

Treatment Details

Interventions

• Psilocybin

Trial Overview The study compares two groups: one receives standard group therapy with breathwork, while the other gets the same plus a single dose of psilocybin. The goal is to see if psilocybin can enhance the effectiveness of group therapy for first responders.

Participant Groups

Group I: Active Group Experimental Treatment 1 Intervention

All participants will undergo a 12-week, group-based program (one session per week, for 12 weeks). The first group session, as well as the Week 10 session will occur in-person. The remainder of the sessions will occur remotely. Each week, trained facilitators will help create a trauma-informed safe space for the group to thrive and promote cognitive resilience. The topics covered throughout the 12-week program include breath-work, mindfulness, self-compassion, embodiment, and Internal Family Systems work. During Week 10, participants will be provided with either psilocybin (active group) or complete a breathwork day (control group). For participants randomized to the active group, they will receive 10mg of psilocybin on Week 10. A clinician certified and trained in the therapeutic use of psilocybin will be on site for participants in the psilocybin group.

Psilocybin is already approved in United States, European Union for the following indications:

Approved in United States as Psilocybin for:

• Treatment-resistant depression (TRD) under Breakthrough Therapy designation

Approved in European Union as Psilocybin for:

• Treatment-resistant depression (TRD) under PRIME designation

Who Is Running the Clinical Trial?

Empower Research Inc

Lead Sponsor

Trials

3

Recruited

210+

Centre for Neurology Studies, Canada

Collaborator

Trials

1

Recruited

30+

Empower Psychedelics

Collaborator

Trials

1

Recruited

30+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+

Findings from Research

Psilocybin shows promising effects in alleviating anxiety, depression, and emotional distress in palliative care patients, with a favorable safety profile, based on recent studies and reports.

Despite its potential benefits, psilocybin is not yet approved for therapeutic use in the U.S., and significant barriers exist for access, particularly for vulnerable populations like the elderly and those in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin in Palliative Care: An Update. Whinkin, E., Opalka, M., Watters, C., et al.[2023]

Psilocybin has shown promise in reducing symptoms of depression and anxiety, particularly in cancer patients, with effects lasting for at least six months after a single treatment, based on three controlled studies.

In small pilot studies, psilocybin has also demonstrated potential effectiveness in treating addiction to alcohol and cigarettes, suggesting its versatility as a therapeutic agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Therapeutic Effects of Psilocybin: A Systematic Review. Goel, DB., Zilate, S.[2022]

Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.

Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. Passie, T., Seifert, J., Schneider, U., et al.[2016]

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.

The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

In a study involving 12 healthy adults, escalating doses of psilocybin (0.3, 0.45, and 0.6 mg/kg) were administered safely, with no serious adverse events reported, indicating a favorable safety profile for this psychedelic compound.

The pharmacokinetics of psilocin, the active metabolite of psilocybin, were linear across the tested doses, with an elimination half-life of about 3 hours, suggesting that no dose adjustments are necessary for individuals with mild to moderate renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Brown, RT., Nicholas, CR., Cozzi, NV., et al.[2022]

Psilocybin-containing mushrooms, commonly known as hallucinogenic or 'magic' mushrooms, rapidly affect the central nervous system within 0.5-1 hour of ingestion, leading to effects such as ataxia, hyperkinesis, and hallucinations.

The review discusses the significant toxicity associated with these mushrooms, highlighting the need for awareness and understanding of their pharmacology, clinical effects, and potential treatment for adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

A 30-year-old man experienced severe symptoms, including vomiting and muscle pain, after receiving an intravenous injection of Psilocybe mushroom extract, highlighting the potential dangers of using hallucinogenic substances in non-traditional ways.

The patient showed rapid improvement with supportive care, suggesting that while the effects of Psilocybe mushrooms can be serious, timely medical intervention can effectively manage the symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. Curry, SC., Rose, MC.[2019]

In a survey of 1993 individuals who experienced challenging psilocybin trips, 39% rated their experience as one of the most difficult of their lives, with 11% reporting risks of physical harm, particularly influenced by dose and lack of support.

Despite the challenges, 84% of respondents felt they benefited from the experience, suggesting that while adverse effects can occur, the overall incidence of serious psychological distress is low, especially in controlled settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. Carbonaro, TM., Bradstreet, MP., Barrett, FS., et al.[2018]

A meta-analysis of psilocybin studies found that higher doses of psilocybin are associated with stronger subjective experiences, particularly in areas like perceptual alterations and ego dissolution, based on data from standardized questionnaires.

Challenging experiences were less affected by dose, suggesting that individual and environmental factors also play a significant role in the psilocybin experience, indicating that these findings are most relevant in controlled settings rather than recreational use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response relationships of psilocybin-induced subjective experiences in humans. Hirschfeld, T., Schmidt, TT.[2022]

Out of 9233 magic mushroom users surveyed, only 19 (0.2%) sought emergency medical treatment, indicating that serious adverse reactions are quite rare and typically short-lived.

The most common adverse effects were psychological, such as anxiety and paranoia, often linked to poor mindset or setting, suggesting that providing harm-reduction information could help prevent these incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse experiences resulting in emergency medical treatment seeking following the use of magic mushrooms. Kopra, EI., Ferris, JA., Winstock, AR., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Psilocybin in Palliative Care: An Update. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Potential Therapeutic Effects of Psilocybin: A Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Dose-response relationships of psilocybin-induced subjective experiences in humans. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse experiences resulting in emergency medical treatment seeking following the use of magic mushrooms. [2022]