Ayahuasca, Esketamine and Premenstrual Symptoms
This randomized, double‑blind trial (n=20) will assess the effects of a single oral dose of ayahuasca versus oral esketamine on the menstrual cycle and premenstrual symptoms in healthy women aged 18–65, with the primary outcome measured by the Premenstrual Symptom Tracking Instrument (PSST) from enrolment to three weeks. Participants will be allocated in a parallel design to an experimental arm receiving oral ayahuasca or an active comparator arm receiving oral esketamine under double‑blind conditions. The study is described as basic science, enrols healthy female volunteers without psychiatric or other medical comorbidities, has estimated enrolment of 20, and is scheduled to start on 20 December 2025 with completion anticipated in July 2026.
Detailed Description
Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on premenstrual symptoms.
Study Arms & Interventions
ayahuasca
experimentaloral ayahuasca
Interventions
- Ayahuasca
esketamine
active comparatororal esketamine
Interventions
- Esketamine
Participants
Inclusion Criteria
- healthy volunteers
Exclusion Criteria
- psychiatric and other medical comorbidities
Study Details
- StatusRecruiting
- PhasePhase NA
- Typeinterventional
- DesignRandomizeddouble Blind
- Target Enrollment20 participants
- TimelineStart: 2025-12-20End: 2026-07-01
- Compounds
Study Team
Sponsors & Collaborators
- University of São PauloPrimary Sponsor