Phase I psilocybin safety trial ATMA

Phase I open-label single-arm safety study of a single 25 mg oral psilocybin dose in healthy participants enrolled in an 8-week psychedelic-assisted therapy training programme (n=14).

Safety assessments included blood pressure, heart rate, temperature and ECG during the session (hourly or as needed) and adverse events recorded at 2 days, 7 days and 8 weeks; mood and mystical experience were measured via QIDS-SR16 and MEQ-30.

Individual participant data are available in a public repository (figshare DOI https://doi.org/10.6084/m9.figshare.22329433.v1).

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

1. 18 - 65 years old and healthy as determined by a physician
2. Must be a practising mental healthcare provider with professional accreditation (eg psychiatrist, psychologist, registered psychiatric nurse, social worker, physician, licensed practical nurse, counsellor, 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 NSAIDs 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 transport available after the Experimental Session and through the following day 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 enrollment through 10 days after the Experimental Session
12. Must provide a contact (relative, spouse, close friend, or other caregiver) reachable by the investigator in an emergency
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 recognised language of the study site
15. Agree not to 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 programme
17. Have approval from family physician before enrolment to ensure physical and psychological fitness
18. Participants must agree to be delivered to the care of a responsible individual who can observe the participant for 24 hours post-dose

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 haemorrhage, hepatic cirrhosis, hepatorenal disease
4. Deemed not suitable for the treatment programme by the qualified investigator
5. Are not able to give adequate informed consent
6. Are pregnant, nursing, or of childbearing potential and not willing to practise effective birth control
7. Present with suicide risk, as determined through clinical interview and responses to C-SSRS
8. Have uncontrolled hypertension (≥140/90 mmHg on three occasions) or history of ventricular arrhythmia (other than occasional PVCs in absence of ischaemic heart disease)
9. Have Wolff–Parkinson–White syndrome or other accessory pathway not successfully eliminated by ablation
10. Previous experience with psilocybin demonstrating poor tolerance or significant adverse event after prior hallucinogen use
11. History of schizophrenia, or first-degree relatives with schizophrenia
12. Known sensitivity to psilocybin and/or its metabolites
13. Any clinically significant medical condition or disease
14. QT prolongation or history thereof, or concomitant medications that carry a risk of QT prolongation
Prohibited medications:
1. Known UGT enzyme modulators (inhibitors of UGT1A9 and UGT1A10 discontinued ≥5 half-lives prior to administration)
2. Monoamine oxidase inhibitors (discontinue ≥5 half-lives prior)
3. SSRIs/SNRIs

Company

Product

Legal

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin 25 mg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details