Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans
- Conditions
- Major Depressive DisorderDepression
- Interventions
- Registration Number
- NCT04711915
- Lead Sponsor
- Yale University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 0.1 mg/kg DMT 0.1 mg/kg Dimethyltryptamine (DMT) 0.1 mg/kg DMT administered intravenously 0.3 mg/kg DMT 0.3 mg/kg Dimethyltryptamine (DMT) 0.3 mg/kg DMT administered intravenously
- Primary Outcome Measures
Name Time Method Change in Blood Pressure -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 +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 -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 -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 -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 +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 Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
🇺🇸West Haven, Connecticut, United States