Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Yale University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
0.1 mg/kg DMT
0.1 mg/kg DMT administered intravenously
Intervention: 0.1 mg/kg Dimethyltryptamine (DMT) (Drug)
0.3 mg/kg DMT
0.3 mg/kg DMT administered intravenously
Intervention: 0.3 mg/kg Dimethyltryptamine (DMT) (Drug)
Outcomes
Primary Outcomes
Change in Blood Pressure
Time Frame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration
Systolic and diastolic blood pressure will be measured before and several times after the administration of DMT on each test day.
Overall Tolerability assessed by the VAS
Time Frame: +120 minutes after DMT administration
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.
Change in Heart Rate
Time Frame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration
Heart rate will be measured before and several times after the administration of DMT on each test day.
Change in Psychedelic Effects
Time Frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration
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.
Change in Anxiety
Time Frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration
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.
Drug Reinforcing Effects
Time Frame: +120 minutes after DMT administration
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Deepak C. D'Souza
Professor of Psychiatry
Yale University