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Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans
Sponsor: Deepak C. D'Souza
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.
Official title: Phase 1 Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans
Key Details
Gender
All
Age Range
21 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-03-14
Completion Date
2027-12-01
Last Updated
2026-06-16
Healthy Volunteers
Yes
Conditions
Interventions
DMT-Medium Dose
14 mg slow intravenous push (bolus) over 5 minutes and then 0.015 mg/kg/min for 55 minutes.
DMT-Low Dose
10 mg slow intravenous push (bolus) over 5 minutes and then 0.01 mg/kg/min for 55 minutes
THC-Medium Dose
0.5 mg over 5 minutes and then 2 mg over and 55 minutes
THC-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