RecruitingPhase 1NCT06671977

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

Phase 1 Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans


Sponsor

Deepak C. D'Souza

Enrollment

60 participants

Start Date

Mar 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is examining the safety, tolerability, and effects of DMT (dimethyltryptamine), a naturally occurring psychedelic compound, in healthy human volunteers and people with certain conditions. Researchers are studying how it affects brain electrical activity and whether it may have therapeutic potential. **You may be eligible if...** - You are between 21 and 65 years old - You are in good general health with a BMI between 18 and 35 - You speak English and can give informed consent - You are willing to avoid alcohol and recreational drugs the day before, day of, and day after each session - Women of childbearing potential must use effective contraception **You may NOT be eligible if...** - You have a personal or family history of psychosis, schizophrenia, or bipolar disorder - You have cardiovascular problems or a history of seizures - You are taking medications that interact with serotonin (like certain antidepressants) - You test positive on a drug screen on the day of a session Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDMT-Medium Dose

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

DRUGDMT-Low Dose

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

DRUGTHC-Medium Dose

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

DRUGTHC-Low Dose

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


Locations(1)

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

West Haven, Connecticut, United States

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NCT06671977


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