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

This interventional trial (n=12) will assess the feasibility and acceptability of administering psilocybin (25mg) to healthy volunteers within a marae setting (Māori) under clinical supervision.

Conducted by the Matai Medical Research Institute and funded by the Health Research Council of New Zealand, this pilot study aims to explore the cultural appropriateness of psilocybin-assisted psychotherapy for Māori populations. The study will incorporate Māori concepts of wairua (spirituality) and tikanga (cultural practice) into the treatment model to enhance the therapeutic environment.

The primary outcomes will be measured through participant recruitment and attrition rates, as well as acceptability gauged via semi-structured interviews one week after psilocybin administration. Participants must be Māori, aged 18-65, and meet specific inclusion criteria, while those with certain psychiatric, substance use, or medical conditions will be excluded.

Recruitment is anticipated to begin in August 2024 and conclude by December 2024. Ethics approval was granted by the Central Health and Disability Ethics Committee in March 2024.

Topic Healthy Subjects Addiction
Compound Psilocybin
Country New Zealand
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 August 2024
End date 31 December 2024
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 12
Sex All
Age 18- 65
Therapy Yes

Trial Details

There has been a recent resurgence in interest in the potential for psychedelic drugs such as psilocybin (the main psychoactive ingredient in “magic mushrooms”) to treat a range of mental health conditions, particularly mood and addictive disorders. Typically, treatment regimens with psychedelic drugs involve combining the drug intervention with psychotherapy – termed psychedelic-assisted therapy. In psychedelic-assisted therapy, outcomes heavily depend on set and setting, that is the mindset of the patient and the physical environment in which the exposure occurs. Psilocybin-assisted psychotherapy has the potential to be a treatment option for a range of substance-use disorders. However, western models of psychedelic therapy cannot be simply translated for Maori populations given that spirituality is a core aspect of both the Maori mental health model and the psychedelic experience. The current project aims to implement a more culturally appropriate psilocybin-assisted psychotherapy model for use by and for Maori populations. This model will have woven into it the Maori concepts of wairua (spirituality) and tikanga (cultural practice) and be delivered in a marae setting to maximise these elements.

NCT Number ACTRN12624000869572

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.