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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

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Non Epileptic Seizures

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03

In context

Seizures

766 studies on the registry are indexed under Seizures; 136 are open to participants now.

This study's planned enrollment of 15 is below the median of 64 across 519 interventional studies indexed under Seizures.

Browse Seizures studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Form; patients with schizophrenia or other psychotic disorders and/or impaired reality testing; and pregnant or breastfeeding women.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

  • Oral dose of ayahuasca (1 ml/kg)

06

What researchers measure

Primary outcomes

  1. Seizure frequency

    Seizure frequency

    Time frame: Baseline, 1, 2, 3 e 4 weeks

  2. Seizure frequency

    Seizure frequency

    Time frame: Baseline, 1, 2, 3 and 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Ribeirão Preto Medical School
    Ribeirão Preto, São Paulo 14048900, Brazil
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Aug 2027, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2026
First posted
Aug 5, 2026
StartActual
Jul 1, 2026
Primary completionEst.
Aug 30, 2027
CompletionEst.
Aug 30, 2027
Last update
Aug 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07747324
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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No contact was published for this record. The registry link below has the sponsor’s details.

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Studies of the drug tested here: Ayahuasca

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