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NCT07317206
Effects of Single Dose of Ayahuasca or Esketamine on Posttraumatic Stress Disorder: a Randomized, Double-blinded Study
Phase 2 trial testing Ayahuasca in Posttraumatic Stress Disorder (PTSD) in 10 participants. Currently enrolling.
1 June 2026
Quick facts
| Lead sponsor | University of Sao Paulo |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 20 December 2025 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 July 2026 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Ayahuasca — full drug profile →
- Esketamine (ESKETAMINE) — full drug profile →
Conditions studied
- Posttraumatic Stress Disorder (PTSD) — all drugs for Posttraumatic Stress Disorder (PTSD) →
Sponsor
University of Sao Paulo
Who can join
Adults 18 to 65, any sex, with Posttraumatic Stress Disorder (PTSD). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Posttraumatic Stress Disorder Checklist for DSM-5
Time frame: From enrollment to the end of treatment at 3 weeks
higher scores mean a worse outcome
Sponsor's own description
Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine in patients with posttraumatic stress disorder.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07317206
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ayahuasca
Trials testing the same drug.
- NCT07212946 — Ayahuasca and Esketamine for Major Depression · Phase 2 · completed
Other recruiting trials for Posttraumatic Stress Disorder (PTSD)
Currently open trials in the same condition.
- NCT07238192 — Augmenting Massed Cognitive Processing Therapy (CPT) to Prevent Suicide Risk Among Patients With PTSD · NA · recruiting
- NCT07146633 — Efficacy of an EMDR App for PTSD and SUD · NA · recruiting
- NCT06685965 — A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances · Phase 2 · recruiting
- NCT06968832 — Project COMET: Massed Prolonged Exposure for PTSD and SUD · NA · recruiting
- NCT07521020 — Mindfulness-based Stress Reduction for PTSD in Road Traffic Accident Victims: A Randomized Controlled Trial · NA · recruiting
Other University of Sao Paulo trials
Trials by the same sponsor.
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- NCT07445178 — Piecemeal Resection and Advanced Histology Independently Predict Local Recurrence After Colorectal Snare-based Endoscopi · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07317206 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo
- Last refreshed: 19 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07317206.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing