drugset / Trial / NCT06671977

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

NCT06671977 ↗

Phase 1 Recruiting 60 enrolled Deepak C. D'Souza
RandomizedCrossoverTriple-blindOther

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.

Timeline

Start
2025-03-14
Primary completion
2027-12-01
Completion
2027-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator DMT Unknown 0.01 mg/kg Intravenous
Comparator DMT Unknown 0.015 mg/kg Intravenous
Comparator THC Unknown 1 mg Intravenous
Comparator THC Unknown 2 mg —