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

NCT ID: NCT04711915

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2026-12-01

Brief Summary

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.

Detailed 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.

Conditions

Major Depressive Disorder; Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

0.1 mg/kg DMT

0.1 mg/kg DMT administered intravenously

Group Type: ACTIVE_COMPARATOR

0.1 mg/kg Dimethyltryptamine (DMT)

Intervention Type: DRUG

0.1 mg/kg DMT

0.3 mg/kg DMT

0.3 mg/kg DMT administered intravenously

Group Type: ACTIVE_COMPARATOR

0.3 mg/kg Dimethyltryptamine (DMT)

Intervention Type: DRUG

0.3 mg/kg DMT

Interventions

0.1 mg/kg Dimethyltryptamine (DMT)

0.1 mg/kg DMT

Intervention Type: DRUG

0.3 mg/kg Dimethyltryptamine (DMT)

0.3 mg/kg DMT

Intervention Type: DRUG

Other Intervention Names

Low Dose DMT; Moderate Dose DMT

Eligibility Criteria

Inclusion Criteria

• Medically healthy
• Psychiatrically healthy

• Medically healthy
• Diagnosis of major depressive disorder

Exclusion Criteria

• Unstable medical conditions
• Psychiatric illness

-Unstable medical conditions

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Deepak C. D'Souza

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000027720

Identifier Type: -

Identifier Source: org_study_id