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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorDeepak C. D'Souza

About this trial

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 criteria

Qualifiers

Males and females

Age 21 to 65 years

Body mass index between 18-35 kg/m2

Willing to refrain from taking any medications not approved by the study physician

Disqualifiers

Medications that might significantly interfere with the effects of the study medications

Cognitive dysfunction that could interfere with study participation

Alcohol or substance use disorder

Any lifetime history of hallucinogen use disorder

Trial design

Treatments tested in this trial

  • DMT-Medium Dose
  • DMT-Low Dose
  • THC-Medium Dose
  • THC-Low Dose

Treatment groups

60 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Deepak C. D'Souza

Lead sponsor

Yale University

Sponsor institution