Clinical TrialHealthy VolunteersPsilocybinCompleted

Phase I psilocybin safety trial ATMA

This Phase I open-label trial (n=14) studied the safety of psilocybin when administered to healthy participants enrolled in a psychedelic-assisted therapy training programme. Participants ingested 25 mg of psilocybin extract, and vital signs, including heart rate, blood pressure, temperature, and ECG, were monitored.

Target Enrollment
14 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

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).

Study Protocol

Preparation

sessions

Dosing

1 sessions
360 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin 25 mg

experimental

Single oral 25 mg psilocybin session in healthy participants enrolled in a training programme.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Oral psilocybin extract; effects reported 4–6 hours.

Participants

Ages
18 – 65
Sexes
Male & Female

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

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment14 participants
  • Timeline
    Start: 2021-10-01
    End: 2022-10-31
  • Compound
    Psilocybin
  • Topic
    Healthy Volunteers

Locations

The Newly Institute — Calgary, Canada

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