Clinical Study of DMT in Healthy Adults

This open-label trial (n=30) seeks to evaluate the acute and subacute effects of inhaled DMT. Participants will be given a low dose (7mg/70kg) and then two hours later a higher dose (49mg/70kg). Participants will not receive psychological support.

Primary outcome measures include the incidence of treatment-emergent adverse events, evaluating clinical and psychiatric acute risks and, physiological measures including heart rate, blood pressure and respiratory rate.

Topic Healthy Subjects
Compound DMT
Country Brazil
Visit trial
Status Completed
Results Published Yes
Start date 01 June 2022
End date 01 December 2022
Chance of happening 89%
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 27
Sex All
Age 18- 65
Therapy No

Trial Details

This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine in healthy individuals. Participants will receive N, N-Dimethyltryptamine administered in two dosing sessions: an initial low-dose safety session and subsequent intermediate-dose treatment, in a fixed order and 2h apart.

NCT Number NCT05573568

Sponsors & Collaborators

University Federal of Rio Grande do Norte
University Federal of Rio Grande do Norte research with psychedelics has been taking place for the past ten years and more.

Papers

Safety and tolerability of inhaled N,N-Dimethyltryptamine (BMND01 candidate): A phase I clinical trial
This open-label, single-ascending, fixed-order dose-response study (n=27) investigates the safety and tolerability of inhaled DMT. The healthy volunteers received varying doses of inhaled DMT (5-60mg). Preliminary findings indicate dose-dependent increases in intensity, valence, and perceptual ratings, with no significant safety concerns, suggesting inhaled DMT as a potentially efficient and safe administration method.

Data attribution

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