An Open-Label Trial Protocol to Test Menstrual Cycle Effects and Tolerance to Low-Dose Psilocybin in Healthy...

Area of Science:

• Neuroscience
• Psychopharmacology
• Women's Health

Background:

• Psychedelic research, particularly on psilocybin, is growing but often neglects the menstrual cycle.
• Hormonal fluctuations during the menstrual cycle may impact the efficacy and safety of psychedelics due to effects on serotonin receptors.
• Understanding these variations is crucial for accurate psychedelic research and therapeutic applications.

Purpose of the Study:

• To assess if low-dose psilocybin response varies across menstrual cycle phases in healthy individuals.
• To investigate potential tolerance effects of psilocybin when administered on consecutive days.
• To address critical gaps in psychedelic research concerning biological variables in menstruating populations.

Main Methods:

• The PsiMenis trial involves two sub-studies (PsiMen-M and PsiMen-T) with healthy participants.
• Psilocybin (5 mg) administered during different cycle phases (PsiMen-M) or on consecutive days (PsiMen-T).
• Measurements include subjective experience (questionnaires), cognitive function (EEG), and pharmacokinetics (blood sampling), alongside safety monitoring.

Main Results:

• This section is to be filled once the study is completed and results are available.

Conclusions:

• The study will clarify if psilocybin effects differ based on menstrual cycle phase, filling a significant gap in psychedelic research.
• Findings could guide the development of treatments for mood disorders linked to the menstrual cycle.
• Results may improve future psychedelic trial designs by incorporating hormonal cycle considerations.