Clinical TrialHealthy VolunteersPsilocybinNot yet recruiting

Pilot study of administration of psilocybin in healthy volunteers within a marae

This interventional trial (n=12) will assess the feasibility and acceptability of administering a single 25 mg oral dose of psilocybin to healthy Māori volunteers in a marae setting under clinical supervision (open-label, single-group, Phase I).

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

Detailed Description

Single-group, open-label Phase I feasibility study enrolling 12 healthy Māori volunteers to receive a single 25 mg oral capsule of psilocybin in a marae setting with clinical and cultural supervision.

Primary outcomes are feasibility and acceptability; safety assessed via adverse events, vitals and screening for suicidality (C-SSRS). Key exclusions include personal or first-degree family history of psychosis, recent psychedelic use, substance dependence, and BMI outside 18–35.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin 25 mg

experimental

Single-group open-label administration of a single 25 mg oral psilocybin capsule in a marae setting under clinical supervision.

Interventions

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

    Single 25 mg oral capsule administered on a marae under clinical supervision; cultural safety procedures in place.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • 1. Provision of signed and dated informed consent form.
  • 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  • 3. Māori, of any gender identity aged 18–65 years.
  • 4. For heterosexually active persons of child-bearing potential: agree to use an effective or highly effective contraception for at least one month prior to screening and for one month after follow-up is completed.
  • 5. For heterosexually active males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner; agree not to donate sperm until at least 3 months after receiving the study drug.

Exclusion Criteria

  • 1. Current or past history of schizophrenia or other psychotic disorders, or bipolar I or II disorder; known first-degree relative with these disorders.
  • 2. Risk of suicide as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS).
  • 3. Current diagnosis of depression, any anxiety disorder, PTSD, or eating disorder (previous diagnoses acceptable if remission stable for ≥3 years).
  • 4. Substance dependence in the previous 6 months as assessed by clinical interview (NM-ASSIST).
  • 5. Problematic alcohol use: AUDIT score ≥16.
  • 6. BMI <18 or >35.
  • 7. Planned or current pregnancy or lactation.
  • 8. Cardiovascular conditions including abnormal HR or BP; exclusion threshold: average systolic >160 mmHg or diastolic >90 mmHg across three assessments on screening day (well-managed hypertension may be allowed).
  • 9. Significant renal or hepatic impairment.
  • 10. Abnormal 12-lead ECG as judged by study physician.
  • 11. Any unstable medical or neurological condition.
  • 12. Regular use of medications/supplements judged contraindicated by study physician.
  • 13. Treatment with another investigational drug or intervention within 2 months.
  • 14. Use of serotonergic psychedelic drugs in the last year.
  • 15. Any other condition judged by the treating clinician as likely to impact ability to complete the trial.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2024-08-01
    End: 2024-12-31
  • Compound
    Psilocybin
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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