PsilocybinPhase 1/2NCT06471959
Psychedelic-assisted Group Program for First Responders
A Phase 1/2 study testing Psilocybin in people with Psilocybin and Psychotherapy, Group, run by Empower Research Inc at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Psilocybin, Psychotherapy, Group
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2025to 1 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 19 to 65 years of age
- Must be a first responder, any work status (Employed full-time or part-time, Off-work, Retired, Volunteer)
- Fluent in English
- Able to understand the informed consent form, study procedures and willing to participate in study
- Clinically diagnosed with a mental health condition such as:
- Depression
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- Chronic anxiety
- Obsessive-compulsive disorder
- PTSD
- Unresolved grief
- Adjustment Disorder
- Acute Stress Disorder
- Stable dose of medications for the last three months, with no changes anticipated for the duration of the study
- Medical clearance by the Investigator (MD) prior to study enrollment
- Willing and able to attend two in-person sessions throughout the 12-week program, in addition to remote sessions
- Concurrent therapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study.
- Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on Week 10. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on Week 10.
- Agree that for one week before the drug sessions, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement (specifically SAM-e, 5-HTP, L-tryptophan, St John's Wort) except when approved by the study Investigator. Exceptions will be evaluated by the Investigator and may include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
- Agree to refrain from consuming alcohol within two days prior to the Week 10 visit.
- 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)
- Normal body mass index (BMI 18.5-24.9)
Who cannot join
- Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, dissociative disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anorexia nervosa, bulimia nervosa or substance abuse, as assessed by medical history
- Presence of active psychotic symptoms
- Currently diagnosed psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain, as assessed by medical history.
- Diagnosis of dementia or delirium
- Risk of suicide as determined by the Investigator
- Significantly intrusive PTSD as determined by the Investigator
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- Extreme emotional lability can be disruptive to the group milieu and is a relative exclusion criterion
- Uncontrolled cardiopulmonary disease, cardiovascular disease, or hypertension
- Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, vascular or any other major concurrent illness that, in the opinion of the Investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study
- Psychoactive substance use (MDMA, psilocybin, LSD) within the previous two months.
- If female and of child-bearing potential: pregnant, suspected or planning to become pregnant during the study
- Participation in another clinical trial (currently or within the last 30 days)
- Current use of rifamycins (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, taxol, dexamethasone); cytochrome P450 Inhibitors - including all HIV protease inhibitors, verapamil, diltiazem, itraconazole, ketoconazole, erythromycin, clarithromycin, azithromycin, and troleandomycin; ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl, warfarin, metoprolol, propranolol, buspirone, tramadol, selegiline, sumatriptan.
- Current use of inhibitors of UGT1A9 and 1A10, monoamine oxidase inhibitors (MAOIs), Tricyclic antidepressants, aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre for Neurology Studies
Surrey, British Columbia, V3V 0C6
Sonia Brodie, CCRP, 604-308-5900, soniabrodie@healthtechconnex.com
Natasha Campbell, ACRP-CP, 778-874-7758, natashacampbell@healthtechconnex.com
About this study
Official title: Assessing the Feasibility of a Custom Psychedelic-assisted Group Program on Mental and Physical Health in First Responders
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
Read the detailed description
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. During the dosing session, the clinicians will respond to whatever needs arise. This may include escorting them to the bathroom, giving them a drink of water. At least two staff (one facilitator and one clinician) will be on site during dosing days.
The dose will be administered in clear capsules with approximately 500ml of water. Aside from the dose provided, the weekly session will continue as usual, with a focus on breath-work, embodiment, and gentle movement on dosing days.
Psilocybin in the study comes in the form of the study drug, PYEX. PYEX is a drug substance which is a partially purified fraction of the extract of Psilocybe cubensis mushroom fruiting bodies. It is a mixture of indole alkaloids, other mushroom fruiting body components and stabilization excipients. The major indole alkaloids present include psilocybin and psilocin (dephosphorylated psilocybin). PEX010 is a capsule for oral administration and is manufactured with PYEX (12.5-14.0% psilocybin), excipients, and HPMC (hydroxypropyl methyl cellulose) capsules.
- Conditions
- Psilocybin, Psychotherapy, Group
- Being tested
- Psilocybin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called PEX010
Psilocybin in the study comes in the form of the study drug, PYEX. PYEX is a drug substance which is a partially purified fraction of the extract of Psilocybe cubensis mushroom fruiting bodies. It is a mixture of indole alkaloids, other mushroom fruiting body components and stabilization excipients. The major indole alkaloids present include psilocybin and psilocin (dephosphorylated psilocybin). PEX010 is a capsule for oral administration and is manufactured with PYEX (12.5-14.0% psilocybin), excipients, and HPMC (hydroxypropyl methyl cellulose) capsules.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | 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. Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target recruitment rate
A minimum recruitment rate of 70% of our target of 36 individuals within 6 months
Measured: Within 6 months
Retention rate
Retention rate of 90% at study completion
Measured: Study Completion (8 months)
Adherence to schedule
Adherence to scheduled study visits at a rate of 90% or higher at study completion.
Measured: Through Study completion (8 months)
Secondary outcomes (1)
Scores on the GAD-7 Anxiety Scale
Scores on the GAD-7 Anxiety scale will be evaluated using a two-way mixed effects ANOVA with a between factor of GROUP and a within factor of TIME to determine the effect of the psilocybin and control interventions on symptoms of anxiety in firefighters. The scale reports scores with a lowest value of 0 representing "Not at all" experiencing the symptoms of what is asked in the questions. The highest score of 3 represents "Nearly every day" experiencing the symptoms of what is asked in the questions.
Measured: Study Completion (8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsilocybinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- One week prior to the dosing session, participants will be given a list of suggested guidelines designed to enhance the psilocybin experience. The suggestions are optional, but compliance will be recorded. Before arriving at the research unit on the morning of the dosing session day, they will be instructed to consume the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning and to eat a light breakfast. Participants in Group 2 (intervention) will be instructed to take ten (10) 1mg capsules at Week 10. Participants will be advised that the capsules should not be opened, chewed, or held in the mouth for an extended period without swallowing.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Empower Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Empower Psychedelics, Centre for Neurology Studies, Canada, Mitacs
- Responsible party
- Sponsor
- Investigators
- Reginald Peters, MD, Principal investigator, University of British Columbia (Clinical Assistant Professor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471959
- Sponsor's protocol ID
- EMP_Psilo_002
- Status last verified
- Jun 2024
- First submitted
- 11 Dec 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of a Custom Psychedelic-assisted Group Program on Mental and Physical Health in First Responders
- ClinicalTrials.gov ID
- NCT06471959
- Acronym / sponsor ID
- EMP_Psilo_002
- Conditions
- Psilocybin, Psychotherapy, Group
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Empower Research IncIndustry (pharma, biotech, devices)
- Collaborators
- Empower Psychedelics, Centre for Neurology Studies, Canada, Mitacs
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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. During the dosing session, the clinicians will respond to whatever needs arise. This may include escorting them to the bathroom, giving them a drink of water. At least two staff (one facilitator and one clinician) will be on site during dosing days.
The dose will be administered in clear capsules with approximately 500ml of water. Aside from the dose provided, the weekly session will continue as usual, with a focus on breath-work, embodiment, and gentle movement on dosing days.
Psilocybin in the study comes in the form of the study drug, PYEX. PYEX is a drug substance which is a partially purified fraction of the extract of Psilocybe cubensis mushroom fruiting bodies. It is a mixture of indole alkaloids, other mushroom fruiting body components and stabilization excipients. The major indole alkaloids present include psilocybin and psilocin (dephosphorylated psilocybin). PEX010 is a capsule for oral administration and is manufactured with PYEX (12.5-14.0% psilocybin), excipients, and HPMC (hydroxypropyl methyl cellulose) capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One week prior to the dosing session, participants will be given a list of suggested guidelines designed to enhance the psilocybin experience. The suggestions are optional, but compliance will be recorded. Before arriving at the research unit on the morning of the dosing session day, they will be instructed to consume the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning and to eat a light breakfast. Participants in Group 2 (intervention) will be instructed to take ten (10) 1mg capsules at Week 10. Participants will be advised that the capsules should not be opened, chewed, or held in the mouth for an extended period without swallowing.
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Drug: PsilocybinAll 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female, 19 to 65 years of age
- Must be a first responder, any work status (Employed full-time or part-time, Off-work, Retired, Volunteer)
- Fluent in English
- Able to understand the informed consent form, study procedures and willing to participate in study
- Clinically diagnosed with a mental health condition such as:
Key exclusion criteria (14 listed)
- Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, dissociative disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anorexia nervosa, bulimia nervosa or substance abuse, as assessed by medical history
- Presence of active psychotic symptoms
- Currently diagnosed psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain, as assessed by medical history.
- Diagnosis of dementia or delirium
- Risk of suicide as determined by the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinAlso: PEX010Psilocybin in the study comes in the form of the study drug, PYEX. PYEX is a drug substance which is a partially purified fraction of the extract of Psilocybe cubensis mushroom fruiting bodies. It is a mixture of indole alkaloids, other mushroom fruiting body components and stabilization excipients. The major indole alkaloids present include psilocybin and psilocin (dephosphorylated psilocybin). PEX010 is a capsule for oral administration and is manufactured with PYEX (12.5-14.0% psilocybin), excipients, and HPMC (hydroxypropyl methyl cellulose) capsules. | Drug | Active Group |
Primary outcome
Target recruitment rate
Time frame: Within 6 months
A minimum recruitment rate of 70% of our target of 36 individuals within 6 months
Retention rate
Time frame: Study Completion (8 months)
Retention rate of 90% at study completion
Adherence to schedule
Time frame: Through Study completion (8 months)
Adherence to scheduled study visits at a rate of 90% or higher at study completion.
1 secondary outcome
Scores on the GAD-7 Anxiety Scale
Time frame: Study Completion (8 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reginald Peters, MD principal investigator
University of British Columbia (Clinical Assistant Professor)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psilocybin in people with Psilocybin and Psychotherapy, Group, run by Empower Research Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natasha Campbell, MSc (1-778-874-7758, natashacampbell@healthtechconnex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target recruitment rate (time frame: Within 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.