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RecruitingNCT07317219Updated Jan 5, 2026

Ayahuasca, Esketamine and Body Image Perception

An interventional study of Ayahuasca and Esketamine in Healthy Women Volunteers, sponsored by University of Sao Paulo. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Dec 2025; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on women body perception.

02

Conditions studied

  • Healthy Women Volunteers
03

In context

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 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 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy volunteers

Exclusion criteria

Exclusion Criteria:

  • psychiatric and other medical comorbidities
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    ayahuasca

    oral ayahuasca

    Drug: Ayahuasca

  • Active comparator
    esketamine

    oral esketamine

    Drug: Esketamine

Interventions

  • DrugAyahuasca

    oral ayahuasca

    Also known as: aya

  • DrugEsketamine

    oral esketamine

    Also known as: ketamine

06

What researchers measure

Primary outcomes

  1. Body Shape Questionnaire

    higher scores mean a worse outcome

    Time frame: From enrollment to the end of treatment at 3 weeks

07

Study locations

1 of 1 sites recruiting
  • Hospital das Clínicas da FMRP-USP
    Ribeirão Preto, São Paulo 14049900, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07317219
Lead sponsor
University of Sao Paulo
Responsible party
Rafael Guimarães dos Santos (PhD, University of Sao Paulo) — Principal investigator
First posted
Jan 5, 2026
Start date
Dec 20, 2025
Primary completion
Jun 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jan 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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