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Trial registered on ANZCTR


Registration number
ACTRN12624000869572
Ethics application status
Approved
Date submitted
26/06/2024
Date registered
16/07/2024
Date last updated
16/07/2024
Date data sharing statement initially provided
16/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of administration of psilocybin in healthy volunteers within a marae setting
Scientific title
Pilot study of the feasibility and acceptability of administration of psilocybin in healthy volunteers within a marae setting
Secondary ID [1] 312407 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine use 334219 0
Condition category
Condition code
Mental Health 330890 330890 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One 25 mg oral capsule dose of psilocybin administered on a marae setting given under clinical supervision
Intervention code [1] 328911 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338645 0
Feasibility
Timepoint [1] 338645 0
Recruitment rate - the number of participants screened per month determined at the conclusion of the study.
Attrition - the proportion of participants who are enrolled in the trial and do not complete all visits determined at the conclusion of the study.
Primary outcome [2] 338646 0
Acceptability
Timepoint [2] 338646 0
At one week post-psilocybin administration follow-up
Secondary outcome [1] 436778 0
Nil
Timepoint [1] 436778 0
Nil

Eligibility
Key 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. Maori, 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 agreement to use such a method 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. These participants must also agree not to donate sperm until at least 3 months after receiving the study drug
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Current or past history of schizophrenia or other psychotic disorders, or bipolar I or II disorder. Also excluded will be individuals with a 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, post-traumatic stress disorder (PTSD), or eating disorder. Previous diagnoses are acceptable provided remission has been stable for at least three years.
4. Substance dependence in the previous 6 months. Use as assessed by clinical interview with a New Zealand modified version of the NIDA (National Institute of Drug Abuse) Modified Alcohol, Smoking and Substance. Involvement Screening Test (NM-ASSIST).
5. Problematic use of alcohol defined as a score on the Alcohol Use Disorders Identification Test (AUDIT) of 16 or greater.
6. Body Mass Index (BMI) <18 and > 35.
7. Planned or current pregnancy or lactation.
8. Cardiovascular conditions including abnormal heart rate or blood pressure to be checked at screening. A threshold of exceeding 160 mmHg (systolic) and 90 mmHg (diastolic) averaged across three assessments taken on the screening day will be used. Participants with well-managed hypertension would not be excluded.
9. Significant renal or hepatic impairment.
10. Abnormal 12-lead electrocardiogram (ECG) as judged by a study physician.
11. Any unstable medical or neurological condition.
12. Regular use of any medication/supplements deemed to be contraindicating as judged by a study physician
13. Treatment with another investigational drug or other 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 on the ability of the participant to complete the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 26397 0
New Zealand
State/province [1] 26397 0

Funding & Sponsors
Funding source category [1] 316817 0
Government body
Name [1] 316817 0
Health Research Council of New Zealand
Country [1] 316817 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Matai Medical Research Institute
Address
Country
New Zealand
Secondary sponsor category [1] 319046 0
None
Name [1] 319046 0
Address [1] 319046 0
Country [1] 319046 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315587 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 315587 0
https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
Ethics committee country [1] 315587 0
New Zealand
Date submitted for ethics approval [1] 315587 0
19/01/2024
Approval date [1] 315587 0
14/03/2024
Ethics approval number [1] 315587 0

Summary
Brief summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135158 0
Dr Patrick McHugh
Address 135158 0
Matai Medical Research Institute, 400 Childers Rd, Gisborne, 4010
Country 135158 0
New Zealand
Phone 135158 0
+64 06 863 1425
Fax 135158 0
Email 135158 0
[email protected]
Contact person for public queries
Name 135159 0
Patrick McHugh
Address 135159 0
Matai Medical Research Institute, 400 Childers Rd, Gisborne, 4010
Country 135159 0
New Zealand
Phone 135159 0
+64 06 863 1425
Fax 135159 0
Email 135159 0
[email protected]
Contact person for scientific queries
Name 135160 0
Patrick McHugh
Address 135160 0
Matai Medical Research Institute, 400 Childers Rd, Gisborne, 4010
Country 135160 0
New Zealand
Phone 135160 0
+64 06 863 1425
Fax 135160 0
Email 135160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.