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Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans

NCT06671977 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-02

No results posted yet for this study

Summary

The goal of this phase 1 study is to investigate the safety and efficacy of dimethyltryptamine (DMT) in individuals with depression and healthy controls. We hypothesize that administration of DMT will result in decreases in depression, associated symptoms, and neuroplastic changes in depressed subjects. We expect that DMT will induce changes in neuroplasticity as indexed using electroencephalographic (EEG) measures and tasks in both depressed individuals and healthy volunteers, though to different degrees. 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.

Conditions

Interventions

DRUG

DMT-Medium Dose

14 mg slow intravenous push (bolus) over 5 minutes and then 0.015 mg/kg/min for 55 minutes.

DRUG

DMT-Low Dose

10 mg slow intravenous push (bolus) over 5 minutes and then 0.01 mg/kg/min for 55 minutes

DRUG

THC-Medium Dose

0.5 mg over 5 minutes and then 2 mg over and 55 minutes

DRUG

THC-Low Dose

0.1 mg slow intravenous push (bolus) over 5 minutes and then I mg over 55 minutes

Sponsors & Collaborators

  • Deepak C. D'Souza

    lead OTHER

Principal Investigators

  • Deepak D'Souza, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2027-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06671977 on ClinicalTrials.gov