Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04711915

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine

West Haven, Connecticut, 06516, United States

About this study

The results of this study will inform the doses to be used in a larger, double-blind, randomized, placebo-controlled, crossover study. Since the goal of the open label study is to inform the double-blind, randomized, placebo-controlled study, the investigators are citing the hypothesis of the latter solely for providing context. The investigators hypothesize that the administration of DMT will result in neuroplastic changes in healthy and depressed subjects. These changes in neuroplasticity will be indexed using electroencephalographic (EEG) measures and tasks. These neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.1 mg/kg Dimethyltryptamine (DMT)

Drug

0.1 mg/kg DMT

Other names: Low Dose DMT

0.3 mg/kg Dimethyltryptamine (DMT)

Drug

0.3 mg/kg DMT

Other names: Moderate Dose DMT

Primary outcomes

  1. Change in Blood Pressure

    Time frame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration

    Systolic and diastolic blood pressure will be measured before and several times after the administration of DMT on each test day.

  2. Change in Heart Rate

    Time frame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration

    Heart rate will be measured before and several times after the administration of DMT on each test day.

  3. Change in Psychedelic Effects

    Time frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration

    The modified Altered States of Consciousness Rating Scale (ASC) will be used to assess drug-induced altered states of consciousness before and several times after drug administration. This is a 23-item subjective rating scale that will be completed using a visual analog scale format. Questions are scored 0 to 100 each; higher numbers indicate greater psychedelic effects.

  4. Change in Anxiety

    Time frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration

    Anxiety will be assessed using a visual analog scale that subjects will be asked to score from 0 (not at all) to 100 (worst ever) to capture the net anxiety produced by DMT. This will be collected before and several times after DMT administration.

  5. Drug Reinforcing Effects

    Time frame: +120 minutes after DMT administration

    Subjects will be asked to answer questions such as (1) How likely are you to use this drug? and (2) How much are you willing to pay for this experience? using a visual analog scale.

  6. Overall Tolerability assessed by the VAS

    Time frame: +120 minutes after DMT administration

    Overall tolerability will be assessed using a visual analog scale that subjects will be asked to score from 0 (well tolerated) to 100 (intolerable) to capture the net tolerability of DMT.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2021
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.