RecruitingNCT07747324Updated Aug 5, 2026

Effects of a Sigle Dose of Ayahuasca in Patients With Psychogenic Non-epileptic Seizures: an Open Label Clinical Trial

A Phase 1/2 interventional study of Ayahuasca in Non Epileptic Seizures, sponsored by University of Sao Paulo. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by University of Sao Paulo · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 15
Allocation: Not applicable
Ages: 18 Years to 60 Years
Sex: All

Study summary

Open label intervention with a single dose of ayahuasca in patients with psychogenic non-epileptic seizures (PNES)

Conditions studied

Non Epileptic Seizures

Browse trials for

Seizures 881

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients aged 18 to 60 with documented PNES (confirmed via VEEG), without a diagnosis of comorbid epilepsy, and currently receiving follow-up care at outpatient clinics. To enroll in the study, patients must undergo a gradual reduction and discontinuation of any psychotropic medications (antidepressants, antipsychotics, benzodiazepines, or mood stabilizers/anticonvulsants) they are currently taking, in order to avoid drug interactions with-or influence on-the effects of ayahuasca.

Exclusion criteria

Exclusion Criteria:

Patients who have not experienced psychogenic seizures in the last 3 months; patients diagnosed with epilepsy; patients who refuse to reduce or discontinue their current psychotropic medications; patients with a history of prior ayahuasca use; patients with a history of substance use disorder; patients who refuse to sign the Informed Consent Form; patients with schizophrenia or other psychotic disorders and/or impaired reality testing; and pregnant or breastfeeding women.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 15 participants (estimated)

Study arms

Experimental
Ayahuasca
single oral dose of ayahuasca (1 ml/kg)
Drug: Ayahuasca

Interventions

DrugAyahuasca
Oral dose of ayahuasca (1 ml/kg)

What researchers measure

Primary outcomes

Seizure frequency
Seizure frequency
Time frame: Baseline, 1, 2, 3 e 4 weeks
Seizure frequency
Seizure frequency
Time frame: Baseline, 1, 2, 3 and 4 weeks

Study locations

1 of 1 sites recruiting

Ribeirão Preto Medical School
Ribeirão Preto, São Paulo 14048900, Brazil
- Rafael dos Santos, PhD · Contact · banisteria@gmail.com · +551636022703
Recruiting

Registry details

Key details

Study ID: NCT07747324
Lead sponsor: University of Sao Paulo
Responsible party: Rafael Guimarães dos Santos (PhD, Professor, University of Sao Paulo) — Principal investigator
First posted: Aug 5, 2026
Start date: Jul 1, 2026
Primary completion: Aug 30, 2027 (estimated)
Completion: Aug 30, 2027 (estimated)
Last update: Aug 5, 2026

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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