None listed
Conditions
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.
Interventions
One 25 mg oral capsule dose of psilocybin administered on a marae setting given under clinical supervision
Sponsors
Matai Medical Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
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.
Outcome results
None listed