Psychedelic-assisted Group Program for First... — Clinical Trial Details

Two-group, randomised, open-label feasibility study (n=32) testing a 12-week group-based programme for firefighters with a single 10 mg oral psilocybin dosing session at Week 10 (active group) versus the same programme with a breathwork day (control).

Participants attend weekly group sessions (12 total); first and Week 10 sessions are in-person, others remote. Week 10 dosing is given as ten 1 mg capsules (PEX010/PYEX) with a clinician and facilitator on site to support participants.

Assessments occur at baseline, mid-program (Week 6), end of program (Week 12) and 6-month follow-up; primary aims focus on feasibility, implementation and effects on interpersonal functioning and resilience.

Participants

Ages

19 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
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:
1. Depression
2. Chronic anxiety
3. Obsessive-compulsive disorder
4. PTSD
5. Unresolved grief
6. Adjustment Disorder
7. 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)

Exclusion Criteria

Exclusion Criteria:
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
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).

Company

Product

Legal

Psychedelic-assisted Group Program for First Responders

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin + programme

Interventions

Group programme (control)

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators