Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans

Yale University

Status and phase: Active, not recruiting; Phase 1

Conditions: Major Depressive Disorder; Depression

Treatments: Drug: 0.1 mg/kg Dimethyltryptamine (DMT); Drug: 0.3 mg/kg Dimethyltryptamine (DMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04711915

2000027720

Details and patient eligibility

About

The goal of this fixed order, open-label, dose-escalation study is to investigate the safety and efficacy of specific doses of dimethyltryptamine (DMT) in humans.

Full description

The results of this study will inform the doses to be used in a larger, double-blind, randomized, placebo-controlled, crossover study. Since the goal of the open label study is to inform the double-blind, randomized, placebo-controlled study, the investigators are citing the hypothesis of the latter solely for providing context. The investigators hypothesize that the administration of DMT will result in neuroplastic changes in healthy and depressed subjects. These changes in neuroplasticity will be indexed using electroencephalographic (EEG) measures and tasks. 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy controls inclusion criteria:

• Medically healthy
• Psychiatrically healthy

Healthy controls exclusion criteria:

• Unstable medical conditions
• Psychiatric illness

Depression inclusion criteria:

• Medically healthy
• Diagnosis of major depressive disorder

Depression exclusion criteria:

-Unstable medical conditions

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

0.1 mg/kg DMT

Active Comparator group

Description:

0.1 mg/kg DMT administered intravenously

Treatment:

Drug: 0.1 mg/kg Dimethyltryptamine (DMT)

0.3 mg/kg DMT

Active Comparator group

Description:

0.3 mg/kg DMT administered intravenously

Treatment:

Drug: 0.3 mg/kg Dimethyltryptamine (DMT)