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

DMT

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.

Intervention / Treatment

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.
  • 0.1 mg/kg Dimethyltryptamine (DMT) (DRUG)
    0.1 mg/kg DMT
  • 0.3 mg/kg Dimethyltryptamine (DMT) (DRUG)
    0.3 mg/kg DMT

Condition or Disease

  • Major Depressive Disorder
  • Depression

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Active, not recruiting
    Study results: No Results Available
    Age: 21 Years to 65 Years
    Enrollment: 30 (ESTIMATED)
    Funded by: Other
    Allocation: Non-Randomized
    Primary Purpose: Other

    Masking

    Clinical Trial Dates

    Start date: Mar 17, 2021 ACTUAL
    Primary Completion: Dec 01, 2023 ESTIMATED
    Completion Date: Jun 01, 2024 ESTIMATED
    Study First Posted: Jan 15, 2021 ACTUAL
    Last Updated: Feb 28, 2023

    Sponsors / Collaborators

    Lead Sponsor: Yale University
    Responsible Party: Deepak Cyril D'Souza

    Location

    West Haven, Connecticut, USA

    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.

    Participant Groups

    • 0.1 mg/kg DMT administered intravenously

    • 0.3 mg/kg DMT administered intravenously

    Eligibility Criteria

    Sex: All
    Minimum Age: 21
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

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

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

    • 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.

    • 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.

    • 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.

    • 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.

    More Details

    NCT Number: NCT04711915
    Other IDs: 2000027720
    Study URL: https://clinicaltrials.gov/study/NCT04711915
    Last updated: Oct 02, 2023