Documenting psilocybin safety in healthy participants Not Applicable
Conditions
Interventions
25 mg of oral psilocybin, with a duration of effects lasting 4-6 hours.
Sponsors
ATMA Journey Centers Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 - 65 years old and healthy as determined by a physician 2. Must be a practicing mental healthcare provider with professional accreditation including but not limited to a psychiatrist, psychologist, registered psychiatric nurse, social worker, physician, licensed practical nurse, counsellor, and therapist 3. Signed the Research Informed Consent Form 4. Are learning to conduct psilocybin-assisted psychotherapy or psilocybin research 5. Are willing to commit to medication dosing (including swallowing pills), study session attendance, and evaluation instruments 6. Agree that, for approximately 1 week preceding the Experimental Session will refrain from: 6.1. Taking any herbal or dietary supplement (except with prior approval of the research team) 6.2. Taking any non-prescription medications (with the exception of non-steroidal anti-inflammatory drugs or acetaminophen) unless with prior approval of the research team 6.3. Taking any prescription medications (with the exception of prescribed contraception, thyroid hormones, or other medications approved by the research team) 7. Agree to take nothing by mouth except alcohol-free liquids and approved medications after 12:00 A.M. (midnight) the evening before the Experimental Session 8. Agree not to use caffeine or nicotine for 2 hours before and 6 hours after initial drug administration 9. Agree to not operate a vehicle for at least 24 hours after initial drug administration. Participants must have transportation available after the Experimental Session and through the following day, for traveling back for the Integrative Session. 10. Are willing to be contacted via telephone for all necessary telephone contacts 11. If of childbearing potential, must have a negative pregnancy test at study entry and prior to the Experiential Session and must agree to use adequate birth control from the time of enrollment through 10 days after the Experimental Session. Adequate forms of birth control include double barrier methods, such as: 11.1. Male condom with diaphragm 11.2. Male condom with cervical cap If possible, highly effective forms of birth control may be used, including: 11.3. Oral contraceptives 11.4. Patch 11.5. Vaginal ring 11.6. Injectables 11.7. Implants 12. Must provide a contact (relative, spouse, close friend, or other caregiver) who is willing and able to be reached by the investigator in the event of an emergency or if the participant is unreachable 13. Must agree to inform the investigator within 48 hours if any medical conditions occur or medical procedures are planned 14. Are proficient in speaking and reading the predominately used or recognized language of the study site 15. Agree to not participate in any other interventional clinical trials for the duration of this study 16. Participants must be enrolled in the ATMA 8-week psychedelic-assisted therapy training program 17. Have approval from family physician before enrollment to ensure they are physically and psychologically fit to proceed in the trial 18. Participants mu
Exclusion criteria
Exclusion criteria: 1. Presence or history of active psychotic symptoms or diagnosis of bipolar disorder or first- or second-degree relative with a history of same 2. Are on any psychotropic medications including SSRIs, SNRIs, or lithium 3. Diagnosis of dementia/delirium, high risk for coronary artery disease, uncontrolled cardiopulmonary disease/ cardiovascular disease/hypertension, aneurysm, history of intracerebral hemorrhage, hepatic cirrhosis, hepatorenal disease 4. Deemed not suitable for the treatment program by the qualified investigator 5. Are not able to give adequate informed consent 6. Are pregnant, nursing, or are of childbearing potential and not willing to practice an effective means of birth control 7. Present with suicide risk, as determined through clinical interview and responses to C-SSRS will be excluded 8. Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 mmHg or higher assessed on three separate occasions). Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease. 9. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation 10. Have previous experience with psilocybin demonstrating it is not well tolerated, or otherwise experienced a significant adverse event after prior hallucinogen use 11. A history of schizophrenia, or first-degree relatives with schizophrenia 12. Have a known sensitivity to psilocybin and/or its metabolites 13. Have any clinically significant medical condition or disease 14. Have QT prolongation, or a history of QT prolongation, and those who are on concomitant medications that carry a risk of QT prolongation Prohibited medications: 1. Known uridine diphosphate glucuronosyltransferase enzyme modulators. Inhibitors of UGT1A9 and 1A10 must be discontinued at least 5 half-lives prior to psilocybin administration 2. Monoamine oxidase inhibitors. Monoamine oxidase and aldehyde or alcohol dehydrogenase inhibitors must be discontinued at least 5 half-lives prior to psilocybin administration 3. Selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety was assessed via blood pressure, heart rate, temperature, and ECG measurements at baseline, during the psilocybin session at 1-h intervals or as deemed necessary by the Primary Investigator, and at 8 weeks following the psilocybin session 2. Adverse events recorded at 2 days, 7 days, and 8 weeks following the psilocybin session | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mood evaluated via the Quick Inventory of Depressive Symptomatology Self-Report 16-Item Questionnaire (QIDS-SR16) at baseline, 2 days, 7 days, and 8 weeks following the psilocybin session 2. Mystical experience evaluated via the Revised Mystical Experience Questionnaire 30-Item (MEQ-30) at 2 days and 7 days after the psilocybin session | — |
Countries
Canada
Outcome results
None listed