This double-blind, placebo-controlled crossover trial (n=31) aims to investigate the effects of N,N-dimethyltryptamine (DMT) in healthy subjects. DMT is a naturally-occurring psychedelic substance commonly used in recreational and spiritual contexts. The study focuses on intravenous administration of DMT to induce an altered state of consciousness.
Four different intravenous DMT administration schedules, including varying doses and bolus/maintenance perfusion conditions, are tested. The study aims to examine the subjective and autonomic effects of DMT in healthy subjects. The primary outcome measures include the altered states of consciousness profile and subjective effect ratings over time. Secondary outcome measures include subjective mood ratings, mystical-type experiences, autonomic effects, plasma levels of DMT, plasma levels of blood-derived neurotrophic factor (BDNF), plasma levels of oxytocin, renal clearance of DMT, effect moderation through personality traits, and adverse effects. The study started on June 18, 2021, and was completed on September 22, 2022. It was conducted at the University Hospital in Basel, Switzerland.
Trial Details
N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings in the form of Ayahuasca. Similar to lysergic acid diethylamide (LSD) or psilocybin, DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. Pharmacologically, DMT interacts with the serotonin 5-HT2A receptor similar to other classic hallucinogens including LSD and psilocybin. The main difference of DMT in comparison with LSD or psilocybin is inactivity when administered orally without monoamine oxidase (MAO) A inhibition and its short action when administered intravenously or by inhalation. In Ayahuasca, DMT is consumed iin combination with harmala alkaloids that inhibit MAO to increase the oral bioavailability of DMT and to prolong its action after oral use. Alternatively, an intravenous administration regime including a bolus and a one hour maintenance perfusion has been proposed to induce a stable and prolonged DMT experience, allowing to study the psychological and autonomic acute effects of DMT. Also, the maintenance perfusion administration allows to end an altered state of consciousness quickly. In the present study this model will be tested using four modified administration schemes. The goal of this study is to experimentally test different intravenous DMT administration schedules to investigate the subjective and autonomic effects of DMT in healthy subjects. The study is expected to inform researchers on dosing regimes of intravenous DMT as a tool to examine alterations of the mind and is of interest for psychology and psychiatry. This study does not intend to provide any therapeutic benefit for the participants. Currently, no study has validly determined the elimination half-life of DMT and other pharmacokinetic parameters. The key aim is to test the dose-response of DMT as well as the difference between the loading dose bolus and no-bolus perfusion conditions regarding pharmacokinetic, subjective, and autonomic effects including psychological and physical tolerability.NCT Number NCT04353024
Sponsors & Collaborators
University of BaselThe University of Basel Department of Biomedicine hosts the Liechti Lab research group, headed by Matthias Liechti.
MindMed
MindMed is one of the largest companies in the psychedelics space and is developing various psychedelics for mental health disorders.
Papers
Acute effects of intravenous DMT in a randomized placebo-controlled study in healthy participantsThis double-blind, placebo-controlled crossover trial (n=27) investigated different intravenous DMT administration regimens, including placebo, low and high infusion (0.6-1mg/min), and bolus doses (15-25mg) combined with low and high infusion. The study found that bolus doses rapidly induced intense psychedelic effects, with infusions causing slowly increasing, dose-dependent effects.