Pilot study of administration of psilocybin in... — Clinical Trial Details

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.

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

18 - 35

Psychosis History

Excluded

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.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin 25 mg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details