Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 65

Single-dose ayahuasca versus esketamine for PTSD

Official title: Effects of Single Dose of Ayahuasca or Esketamine on Posttraumatic Stress Disorder: a Randomized, Double-blinded Study

Run by University of Sao Paulo · NCT07317206 · Data updated 2026-11-12

This study will try a single dose of ayahuasca or esketamine to see if it quickly reduces symptoms in adults with PTSD.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment10 (estimated)
SponsorUniversity of Sao Paulo
Academic / other
Locations1 site (Ribeirão Preto, São Paulo)
StatusRecruiting
StartedDecember 20, 2025
Main results expectedJune 2026
Study endsJuly 2026
Registry record updatedJanuary 5, 2026
Trial IDNCT07317206 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults diagnosed with PTSD who do not have significant psychiatric or medical comorbidities and who can attend visits at the Ribeirão Preto site.

Probably not a fit

Patients with unstable medical conditions, major psychiatric comorbidities, or those unable to travel to the study site are unlikely to be eligible and may not benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, double-blind, randomized trial comparing a single dose of oral ayahuasca to a single dose of esketamine in people diagnosed with PTSD. Participants are randomly assigned to one of the two interventions and neither participants nor most study staff know which treatment was given. Symptom ratings, safety monitoring, and follow-up visits are used to track response after the dosing session. People with significant psychiatric or medical comorbidities are excluded and all treatments are administered at the Hospital das Clínicas da FMRP-USP in Ribeirão Preto, São Paulo.

Why it matters

Potential benefit: If successful, a single-dose treatment could provide rapid symptom relief and expand treatment options for people with PTSD.

How similar studies have gone: Prior research shows ketamine-like drugs can produce rapid symptom reductions and small, preliminary studies suggest ayahuasca may help mood and trauma symptoms, but large randomized comparisons remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* posttraumatic stress disorder

Exclusion Criteria:

* psychiatric and other medical comorbidities

Where it's running

  • Hospital das Clínicas da FMRP-USP
    Ribeirão Preto, São Paulo, Brazil
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.