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Recruiting

NCT Number: NCT07317232

Ayahuasca, Esketamine and Premenstrual Symptoms

Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on premenstrual symptoms.

Recruiting

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Key information

Conditions

Healthy Women Volunteers

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da FMRP-USP

Ribeirão Preto, Brazil

Location status: Recruiting

Location contact

Guimarães Santos

CONTACT

[email protected]

5516997721969

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers

Exclusion criteria

  • psychiatric and other medical comorbidities

Treatment and study plan

Ayahuasca

Drug

oral ayahuasca

Other names: aya

Esketamine

Drug

oral esketamine

Other names: ketamine

Primary outcomes

  1. Premenstrual Symptom Tracking Instrument (PSST)

    Time frame: From enrollment to the end of treatment at 3 weeks

    higher scores mean a worse outcome

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Effects of a Single Dose of Ayahuasca or Esketamine on the Menstrual Cycle and Premenstrual Symptoms: a Randomized, Double-Blind Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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