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

NCT04711915 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 2000027720
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder; Depression

Outcome Measures

Primary Outcomes (6)

• Change in Blood Pressure

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

  -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

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

  -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

  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.

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

• Change in Anxiety

  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.

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

• Drug Reinforcing Effects

  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.

  +120 minutes after DMT administration

• Overall Tolerability assessed by the VAS

  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.

  +120 minutes after DMT administration

Study Arms (2)

0.1 mg/kg DMT

ACTIVE COMPARATOR

0.1 mg/kg DMT administered intravenously

Drug: 0.1 mg/kg Dimethyltryptamine (DMT)

0.3 mg/kg DMT

ACTIVE COMPARATOR

0.3 mg/kg DMT administered intravenously

Drug: 0.3 mg/kg Dimethyltryptamine (DMT)

Interventions

0.1 mg/kg Dimethyltryptamine (DMT) DRUG

0.1 mg/kg DMT

Also known as: Low Dose DMT

0.1 mg/kg DMT

0.3 mg/kg Dimethyltryptamine (DMT) DRUG

0.3 mg/kg DMT

Also known as: Moderate Dose DMT

0.3 mg/kg DMT

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically healthy
• Psychiatrically healthy

You may not qualify if:

• Unstable medical conditions
• Psychiatric illness
• Medically healthy
• Diagnosis of major depressive disorder
• Unstable medical conditions

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

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

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

N,N-Dimethyltryptamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: Healthy individuals and patients with major depressive disorder will participate in this study. Subjects will receive 0.1 mg/kg and 0.3 mg/kg DMT in a fixed order across 2 test days.

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 15, 2021
• Study Start: March 17, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

US (1)