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Active, not recruitingPhase 1

Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans

NCT04711915 · Yale University

Closed to entry
Status
Not accepting participants
Phase 1
Phase
30
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The goal of this fixed order, open-label, dose-escalation study is to investigate the safety and efficacy of specific doses of dimethyltryptamine (DMT) in humans.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Blood Pressure

    Measured over -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration

  • Change in Heart Rate

    Measured over -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration

  • Change in Psychedelic Effects

    Measured over -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration

  • Change in Anxiety

    Measured over -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration

  • Drug Reinforcing Effects

    Measured over +120 minutes after DMT administration

  • Overall Tolerability assessed by the VAS

    Measured over +120 minutes after DMT administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Healthy controls inclusion criteria: * Medically healthy * Psychiatrically healthy Healthy controls exclusion criteria: * Unstable medical conditions * Psychiatric illness Depression inclusion criteria: * Medically healthy * Diagnosis of major depressive disorder Depression exclusion criteria: -Unstable medical conditions

Where

1 study site

FacilityCityRegionCountry
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of MedicineWest HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04711915 on ClinicalTrials.gov →

Last updated in the registry 2025-08-03. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

All 49 trials from Yale University →