NCT06671977

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Deepak C. D'Souza · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

• Major Depression Disorder
• Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-14
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-11-04
• Last updated: 2025-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study