Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID07317206

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

Led by University of Sao Paulo · Updated on 2026-01-05

10

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a single dose of oral ayahuasca compared to oral esketamine in adults with posttraumatic stress disorder (PTSD). This phase 2, double-blind, randomized clinical trial aims to understand how these treatments impact PTSD symptoms over a short period. Participants will receive either one dose of oral ayahuasca or oral esketamine as part of the study. The trial is designed with two groups: one receiving ayahuasca and the other receiving esketamine, with neither the participants nor the researchers knowing who receives which treatment during the study. Throughout the three-week study, researchers will monitor participants using the Posttraumatic Stress Disorder Checklist for DSM-5 to assess symptom changes. Participants will be followed from enrollment until the end of treatment to evaluate the effects of the treatments on PTSD symptoms.

CONDITIONS

Brief Title

Ayahuasca, Esketamine and PTSD

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Diagnosis of posttraumatic stress disorder
Not Eligible

You will not qualify if you...

  • Presence of psychiatric or other significant medical comorbidities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 weeks

Participants receive a single dose of either oral ayahuasca or oral esketamine to treat posttraumatic stress disorder.

1 baseline visit and regular follow-up visits during treatment

Trial Site Locations

Total: 1 location

1

Hospital das Clínicas da FMRP-USP

Ribeirão Preto, São Paulo, Brazil, 14049900

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Intrinsic and Novelty-related Sensory Cortical Disinhibition...

Posttraumatic Stress Disorder (PTSD)

Actively Recruiting

1 location

Threat-related Sensory Cortical Disinhibition and SPA Pathol...

Threat-related Sensory Cortical (SC) Disinhibition

Actively Recruiting

1 location

A Phase-2, Double-Blind, Randomized, Placebo-Controlled, Cro...

Posttraumatic Stress Disorder (PTSD)

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here