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CompletedEarly Phase 1

Effects of Different Doses of Ayahuasca on Personality in Healthy Volunteers

NCT07893769 · University of Sao Paulo

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
28
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Randomized, double-blind, placebo-controlled clinical trial that included 28 healthy volunteers allocated to four experimental single dose groups (n = 7 per group) (ayahuasca 0.5 mL/kg, 1.0 mL/kg, 1.5 mL/kg, or placebo)

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

  • Personality assessments (primary outcome) were conducted at baseline and at a 21-day follow-up using the NEO Five-Factor Inventory-Revised (NEO-FFI-R)

    Measured over baseline and 21-day follow-up

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 adults Exclusion Criteria: * history of cardiovascular, hepatic, or neurological diseases; * scores \>10 on the Patient Health Questionnaire-9 (PHQ-9) or Generalized Anxiety Disorder-7 (GAD-7), and any psychiatric diagnosis assessed by the Mini International Neuropsychiatric Interview (M.I.N.I.); * pregnancy/lactation; prior experience with ayahuasca (\>2 lifetime uses); * use of psychoactive medications; * and significant recreational drug use (e.g., cannabis \>20 lifetime uses; other psychedelics \>5 uses).

Where

1 study site

FacilityCityRegionCountry
Universidade de São PauloRibeirão Preto-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.

NCT07893769 on ClinicalTrials.gov →

Last updated in the registry 2026-10-26. Registry records change; this page reflects the data build of 2026-10-30.

Related

Where this trial sits

Substance

All 11 trials from University of Sao Paulo →