CompletedEarly Phase 1

Single-dose Effects of Ayahuasca Compared to Esketamine on Experimentally Induced Pain

NCT07910838 · University of Sao Paulo

Closed to entry

Status

Not accepting participants

Early Phase 1

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

This was a randomized, parallel, double-blind clinical trial with healthy volunteers

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Subjective pain
Measured over 0 to 4 hours post-drug
Pain tolerance
Measured over 0 to 4 hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 50 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: \- healthy volunteers Exclusion Criteria: * included history of cardiovascular, liver, or neurological diseases; * pain disorders and/or reports of chronic or acute pain (self-reported); * a score \>10 on the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scales; * any psychiatric diagnosis evaluated through the International Neuropsychiatric Interview (M.I.N.I; DSM-V); * pregnant or breastfeeding women; * previous experience (\> 2 lifetime uses) with ayahuasca; * use of psychoactive medications (antidepressants, mood stabilizers, anxiolytics, and antipsychotics); * use of other drugs (psychostimulants, maximum of 20 lifetime uses; hallucinogens, maximum of 10 lifetime uses). * In addition, participants could not have experienced any kind of pain in the last seven days, as identified through a pre-existing pain condition checklist questionnaire. -

Where

1 study site

Facility	City	Region	Country
Hospital das Clínicas da FMRP-USP	Ribeirão Preto	São Paulo	Brazil

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record. The registry also holds the most current version of everything above.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07910838 on ClinicalTrials.gov →

Last updated in the registry 2026-11-02. Registry records change; this page reflects the data build of 2026-11-03.

Where this trial sits

Substance

Indication

Healthy Adult Participants3

All 12 trials from University of Sao Paulo →