Single-dose ayahuasca versus esketamine for PTSD
Effects of Single Dose of Ayahuasca or Esketamine on Posttraumatic Stress Disorder: a Randomized, Double-blinded Study
This study will try a single dose of ayahuasca or esketamine to see if it quickly reduces symptoms in adults with PTSD.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (Ribeirão Preto, São Paulo) |
| Trial ID | NCT07317206 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * posttraumatic stress disorder Exclusion Criteria: * psychiatric and other medical comorbidities
Where this trial is running
Ribeirão Preto, São Paulo
- Hospital das Clínicas da FMRP-USP — Ribeirão Preto, São Paulo, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.