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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04711915
• Other study ID #: 2000027720
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 17, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• 0.1 mg/kg Dimethyltryptamine (DMT)
0.1 mg/kg DMT
• 0.3 mg/kg Dimethyltryptamine (DMT)
0.3 mg/kg DMT

Locations

Country	Name	City	State
United States	Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Blood Pressure	Systolic and diastolic blood pressure will be measured before and several times after the administration of DMT on each test day.	-60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration
Primary	Change in Heart Rate	Heart rate will be measured before and several times after the administration of DMT on each test day.	-60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration
Primary	Change in Psychedelic Effects	The modified Altered States of Consciousness Rating Scale (ASC) will be used to assess drug-induced altered states of consciousness before and several times after drug administration. This is a 23-item subjective rating scale that will be completed using a visual analog scale format. Questions are scored 0 to 100 each; higher numbers indicate greater psychedelic effects.	-60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration
Primary	Change in Anxiety	Anxiety will be assessed using a visual analog scale that subjects will be asked to score from 0 (not at all) to 100 (worst ever) to capture the net anxiety produced by DMT. This will be collected before and several times after DMT administration.	-60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration
Primary	Drug Reinforcing Effects	Subjects will be asked to answer questions such as (1) How likely are you to use this drug? and (2) How much are you willing to pay for this experience? using a visual analog scale.	+120 minutes after DMT administration
Primary	Overall Tolerability assessed by the VAS	Overall tolerability will be assessed using a visual analog scale that subjects will be asked to score from 0 (well tolerated) to 100 (intolerable) to capture the net tolerability of DMT.	+120 minutes after DMT administration