An open-label trial to test menstrual cycle... — Clinical Trial Details

The menstrual cycle causes major fluctuations in hormones. Changes to progesterone and estrogen in particular are known to dramatically affect not just reproductive systems but brain function. Females are majorly overrepresented in adverse reactions to common medications which suggests that menstrual cycle linked hormones may not just change disorder symptoms but also the response to drug therapies. We will study how the brain’s response to a drug changes over the menstrual cycle. In this study we will examine how the menstrual cycle may change how females are affected by the drug psilocybin. We will study this by taking blood samples and using standardised questionnaires. We will test the hypotheses that the pharmacokinetics and pharmacodynamics of psilocybin are modified across the menstrual cycle. This research may help to improve treatments by taking the menstrual cycle into account and potentially reduce symptoms and adverse reactions over the menstrual cycle.

1. Inability to adequately communicate in English (both written and spoken).
2. Any item 1-13 of the Premenstrual Symptoms Screening Tool scoring above “mild” and any item A-E scoring above mild.
3. Any current psychiatric diagnosis
4. Confirmed diagnosis of (or first degree relative with) schizophrenia or other psychotic disorder, or bipolar I or II disorder.
5. Risk of suicide as determined by The Columbia-Suicide Severity Rating Scale (C-SSRS).
6. Substance dependence in the previous 6 months 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).
7. Problematic use of alcohol defined as a score on the Alcohol Use Disorders Identification Test (AUDIT) of 16 or greater.
8. Body Mass Index (BMI) 35.
9. Planned or current pregnancy or lactation.
10. 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.
11. Significant renal or hepatic impairment.
12. Diagnosed or probable polycystic ovary syndrome (PCOS)
13. Clinically relevant abnormal 12-lead electrocardiogram as judged by a study physician.
14. Clinically relevant abnormal laboratory test findings as judged by a study physician.
15. Any unstable medical or neurological condition.
16. Regular use of any Central Nervous System active medications in the last three months
17. Use of hormonal contraceptives/steroid hormones in the last three months
18. Regular use of any medication/supplements deemed to be contraindicating as judged by a study physician.
19. Treatment with another investigational drug /intervention within the last 3 months.
20. Use of serotonergic psychedelic drugs in the last 3 months.
21. Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.

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An open-label trial to test menstrual cycle effects and tolerance to low dose psilocybin in healthy menstruating persons (PsiMen).

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