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

Phase 1

• Conditions: Methamphetamine use; Mental Health - Addiction

• Registration Number: ACTRN12624000869572
• Lead Sponsor: Matai Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified