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CompletedNCT07893769Updated Oct 26, 2026

Effects of Different Doses of Ayahuasca on Personality in Healthy Volunteers

An Early Phase 1 interventional study of Ayahuasca and Ayahuasca in Healthy Adult Participants, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by University of Sao Paulo · Early Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Jan 2024, registered Oct 2026).
Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Healthy Adult Participants
03

In context

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 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Healthy adults

Exclusion criteria

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).
05

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    ayahuasca 0.5 mL/kg

    ayahuasca 0.5 mL/kg

    Drug: Ayahuasca

  • Experimental
    ayahuasca 1.0 mL/kg

    ayahuasca 1.0 mL/kg

    Drug: Ayahuasca

  • Experimental
    ayahuasca 1.5 mL/kg

    ayahuasca 1.5 mL/kg

    Drug: Ayahuasca

  • Placebo comparator
    Placebo

    Placebo

    Drug: Ayahuasca · Other: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. 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)

    Units on a Scale (NEO-FFI-R)

    Time frame: baseline and 21-day follow-up

07

Study locations

1 site
  • Universidade de São Paulo
    Ribeirão Preto, Brazil
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07893769
Responsible party
Rafael Guimarães dos Santos (Associate Professor, University of Sao Paulo) — Principal investigator
First posted
Oct 26, 2026
Start date
Jan 1, 2024
Primary completion
Sep 1, 2025
Completion
Sep 1, 2025
Last update
Oct 26, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ayahuasca

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