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 NorteUniversity 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 trialThis 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.