DMT-Medium Dose
14 mg slow intravenous push (bolus) over 5 minutes and then 0.015 mg/kg/min for 55 minutes.
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The goal of this phase 1 study is to investigate the safety and efficacy of dimethyltryptamine (DMT) in individuals with depression and healthy controls. We hypothesize that administration of DMT will result in decreases in depression, associated symptoms, and neuroplastic changes in depressed subjects. We expect that DMT will induce changes in neuroplasticity as indexed using electroencephalographic (EEG) measures and tasks in both depressed individuals and healthy volunteers, though to different degrees. 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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-16
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Registry facts
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Interventions
14 mg slow intravenous push (bolus) over 5 minutes and then 0.015 mg/kg/min for 55 minutes.
10 mg slow intravenous push (bolus) over 5 minutes and then 0.01 mg/kg/min for 55 minutes
0.5 mg over 5 minutes and then 2 mg over and 55 minutes
0.1 mg slow intravenous push (bolus) over 5 minutes and then I mg over 55 minutes
Eligibility
primary outcomes
Time frame: Time Frame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration]blood pressure and heart rate will be measured before, during, and after the dosing on each test day.
Pulse oximetry will be measured continuously.
Time frame: From start Test Day Time points (Minutes): -60, +30, +120.
The 30-item revised Mystical Experience Questionnaire (MEQ30) will be used to measure mystical/psychedelic experiences associated with drugs like psilocybin
Time frame: Test Day Time points (Minutes): -60, +30, +120
To capture the effects of DMT/THC/placebo on perception, thought, and sensory processing, participants will be measured using the Psychotomimetic States Inventory
Time frame: Test Day Time points (Minutes): -60, +30, +120
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 anxiety.
Time frame: From start of test day (-60), +30, and +120.
subjects will be asked to score from 0 (not at all) to 100 (worst ever) to capture the depression.
Time frame: Test Day Time points (Minutes): +150 - +180
The Challenging Experience Questionnaire (CEQ) a 26 item likert-scale style survey will be used to provide a phenomenological profile specifically of challenging aspects of experiences with psilocybin
Time frame: Test Day Time points (Minutes): +120
Will be assessed with questions such as: * How likely are you to use this drug recreationally? 0 (not at all) ------------------------100 (most of all) * How much are you willing to pay for the acute effects that you experienced during the dosing session? $0-------------------$100 Shortly after resolution of effects, participants will be instructed to retroactively rate the highest effects experienced since the last time they were prompted to provide a rating.
Time frame: Test Day Time points (Minutes): -60, +30, +120, 180 (end of test day)
Tolerability defined by the US FDA as "the degree to which overt adverse effects can be tolerated" by a subject was assessed \[60\]. At the end of the test day, after all drug effects have worn off, participants will be asked to score 1) the overall experience on a visual analog scale \[VAS\] (0 = intolerable to 100 = well-tolerated).
Time frame: Resting State EEG: Will be collected the day after each dosing session. [Time Frame: -60 minutes before DMT administration until +180 minutes after DMT administration].
secondary outcomes
Time frame: Subjects will be tested for expectancy effects at screening, and before each dosing session.
Time frame: Time Frame: 0; immediately after DMT administration, and +180 minutes at the end of the study
Subjects will be asked to guess their treatment assignment, the degree of certainty of their guess and the reason for their guess both immediately after the psychedelic dosing session(s) and at the end of the study. Either the James' blinding index (BI) or Bang's BI, will be used to measure the adequacy of the blind.
Time frame: Blood sample measurements will be repeated approximately 0, 20, 30, and 60 minutes after drug administration
Time frame: [Time Frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration]
Time frame: Time Frame: +180 minutes after DMT administration
The Acceptance and Action Questionnaire (AAQ) is a one-factor, likert scale assessment of psychological inflexibility
Publications
No exact PMID-linked public article is currently readable locally.