Dose-finding Study for the Combination of DMT and Harmine in Healthy Subjects (DHTP)

This clinical trial (n=16) aims to compare the pharmacokinetic and pharmacodynamic profiles of DMT and Harmine and their safety and tolerability through six study days with varying doses. Participants will be closely monitored for adverse events and receive continuous psychological support in a controlled environment.

Topic Healthy Subjects
Compound DMT Ayahuasca
Country Switzerland
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Trial Details



Trial Number

Sponsors & Collaborators

Reconnect Labs
Reconnect Labs, a Swiss-based clinical-stage pharmaceutical company, is pioneering the development of Regenerative Therapeutics™ aimed at mental health, leveraging cutting-edge neuroscience and precision psychopharmacology.

Papers

Examining the pharmacokinetic and pharmacodynamic interaction of N,N-dimethyltryptamine and harmine in healthy volunteers: Α factorial dose-escalation study
This single-blind, randomized, two-arm, factorial, dose-finding study (n=16) investigates the pharmacokinetic and pharmacodynamic interactions between DMT and harmine in an ayahuasca-inspired ('pharmahuasca') formulation. Participants received six dose combinations (0–120 mg DMT, 0–180 mg harmine) via a transmucosal delivery system. Results show dose-dependent subjective effects lasting 4–5 hours, with peak plasma levels (Cmax) of 33 ng/mL for DMT and 49 ng/mL for harmine. Harmine increased DMT bioavailability and plasma half-life while altering its metabolism. The formulation demonstrated a favourable safety profile, supporting its potential for further clinical testing in affective disorders.

Population pharmacokinetic-pharmacodynamic modeling of co-administered N,N-dimethyltryptamine and harmine in healthy subjects
This reanalysis of a single-blind, randomized study (n=16) using DMT (0-120mg) with harmine (0-180mg) in an ayahuasca-inspired (‘pharmahuasca’) formulation found that harmine significantly enhanced DMT bioavailability and prolonged absorption, resulting in higher sustained plasma concentrations and increased subjective psychedelic effects, with population pharmacokinetic/pharmacodynamic modeling revealing substantial interindividual variability in clearance, bioavailability, and sensitivity to psychedelic effects.

Data attribution

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