Ayahuasca, Esketamine and PTSD

NCT ID: NCT07317206

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-20

Study Completion Date

2026-07-31

Brief Summary

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Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine in patients with posttraumatic stress disorder.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ayahuasca

oral ayahuasca

Group Type EXPERIMENTAL

Ayahuasca

Intervention Type DRUG

oral ayahuasca

esketamine

oral esketamine

Group Type ACTIVE_COMPARATOR

Esketamine

Intervention Type DRUG

oral esketamine

Interventions

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Ayahuasca

oral ayahuasca

Intervention Type DRUG

Esketamine

oral esketamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* posttraumatic stress disorder

Exclusion Criteria

* psychiatric and other medical comorbidities
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rafael Guimarães dos Santos

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital das Clínicas da FMRP-USP

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Rafael Guimarães Santos

Role: primary

5516997721969

Other Identifiers

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55068322.2.0000.5440

Identifier Type: -

Identifier Source: org_study_id

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