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
Deepak C. D'Souza
60 participants
Mar 14, 2025
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
Plain Language Summary
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Interventions
14 mg slow intravenous push (bolus) over 5 minutes and then 0.015 mg/kg/min for 55 minutes.
10 mg slow intravenous push (bolus) over 5 minutes and then 0.01 mg/kg/min for 55 minutes
0.5 mg over 5 minutes and then 2 mg over and 55 minutes
0.1 mg slow intravenous push (bolus) over 5 minutes and then I mg over 55 minutes
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06671977