Pilot study of the feasibility and acceptability of administration of psilocybin in healthy volunteers within a marae setting

Matai Medical Research Institute0 sites12 target enrollmentJuly 16, 2024

Overview

No summary available.

Registry

who.int

Start Date

July 16, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Matai Medical Research Institute

•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

•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.