NCT05901012 is a Phase 1 clinical trial of N,N-Dimethyltryptamine in Safety Issues, sponsored by Universidade Federal do Rio Grande do Norte.

Who is sponsoring NCT05901012?

NCT05901012 is sponsored by Universidade Federal do Rio Grande do Norte.

What drugs are being tested in NCT05901012?

Interventions in NCT05901012: N,N-Dimethyltryptamine, Placebo.

What condition does NCT05901012 study?

NCT05901012 studies Safety Issues, Healthy Volunteers.

Is NCT05901012 still recruiting?

NCT05901012 is currently completed. Last updated 11 October 2023.

Last reviewed 2023-10-11 · How we verify

NCT05901012

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Tolerability of DMT in Healthy Adults

Completed Phase 1 Last updated 11 October 2023

What this trial tests

Phase 1 trial testing N,N-Dimethyltryptamine in Safety Issues in 25 participants. Completed in 17 July 2023.

Timeline

26 April 2023

Primary endpoint
17 July 2023

17 July 2023

Quick facts

Lead sponsor	Universidade Federal do Rio Grande do Norte
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	25
Start date	26 April 2023
Primary completion	17 July 2023
Estimated completion	17 July 2023
Sites	1 location across Brazil

Drugs / interventions tested

N,N-Dimethyltryptamine — full drug profile →
Placebo

Conditions studied

Safety Issues — all drugs for Safety Issues →
Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Universidade Federal do Rio Grande do Norte — full company profile →

Who can join

Adults 18 to 60, any sex, with Safety Issues or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in healthy individuals.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety, tolerability and subjective effects of vaporized N,N-Dimethyltryptamine: A randomized double-blind clinical trial.
Wießner I, Falchi-Carvalho M, Laborde S, Barros H, et al · · 2025 · cited 1× · PMID 40532423 · DOI 10.1016/j.euroneuro.2025.06.002

Verify or expand the search:

Other trials of N,N-Dimethyltryptamine

Trials testing the same drug.

NCT06094907 — Safety, Tolerability and Antidepressant Effects of DMT in Patients With Depression · Phase 2 · completed
NCT05573568 — Clinical Study of DMT in Healthy Adults · Phase 1 · completed

Other recruiting trials for Safety Issues

Currently open trials in the same condition.

NCT06485141 — BeSMART Secure Storage Counseling in the Inpatient Setting · NA · recruiting
NCT06494527 — A Phase 1 Study to Evaluate the Safety/Tolerability, PK/PD of RG002C0106 Injection in Healthy Adults · Phase 1 · active not recruiting
NCT06189170 — Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients · EARLY_PHASE1 · recruiting
NCT06509490 — NKG2D CAR-T(KD-025) in the Treatment of Advanced NKG2DL+ Solid Tumors · NA · recruiting
NCT06498167 — Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib) · recruiting

Other Universidade Federal do Rio Grande do Norte trials

Trials by the same sponsor.

NCT05459376 — Effect of Dry Cupping Therapy Associated With the McKenzie Method in Patients With Chronic Low Back Pain · NA · not yet recruiting
NCT07099495 — REDUCED FUNCTIONALITY AND KINESIOPHOBIA IN PATIENTS WITH HEART FAILURE: USE OF ALTERNATIVE THERAPEUTIC STRATEGIES · NA · not yet recruiting
NCT05408156 — Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus · NA · not yet recruiting
NCT06424743 — Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training · NA · recruiting
NCT06362499 — Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients. · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05901012 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universidade Federal do Rio Grande do Norte
Last refreshed: 11 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05901012.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing