NCT06671977 · Deepak C. D'Souza
Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans
(DMT-Bolus)
What this study is about
The goal of this phase 1 study is to investigate the safety and effectiveness 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.
View original scientific description
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.
Interventions
DRUG
DMT-Medium Dose
14 mg slow intravenous push (bolus) over 5 minutes and then 0.015 mg/kg/min for 55 minutes.
DRUG
DMT-Low Dose
10 mg slow intravenous push (bolus) over 5 minutes and then 0.01 mg/kg/min for 55 minutes
DRUG
THC-Medium Dose
0.5 mg over 5 minutes and then 2 mg over and 55 minutes
DRUG
THC-Low Dose
0.1 mg slow intravenous push (bolus) over 5 minutes and then I mg over 55 minutes
Primary outcome measures
Safety of Physiological indices
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.
Psychedelic Effects
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
Psychotomimetic Effects
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
Anxiety
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.
Depression
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.
Intensity of the Experience
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
Drug Reinforcing Effects
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.
Tolerability of Overt Adverse Effects
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).
Electrophysiological
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].
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males and females
- Age 21 to 65 years
- Body mass index between 18-35 kg/m2
- Willing to refrain from taking any medications not approved by the study physician
- Willing to refrain from using street drugs and alcohol
- Negative urine drug screen
- Willing and able to abstain from smoking throughout each test session
- Women who are of child-bearing potential (WOCBP) and sexually active must be willing to practice an effective means of birth control
- Willing not to drive to and from the testing session Some Inclusion Criteria for Subjects with MDD:
- Diagnosed with Major Depressive Disorder (MDD)
- Unsatisfactory response to antidepressants
- Engaged in treatment for depression with a clinician and willing to continue treatment for the duration of the study
- Not engaged in treatment
- Consent to allow the research team to communicate with mental health provider.
- Only subjects who get support for participation in the trial from their mental health clinician will be eligible to be enrolled in the study Some Common
Exclusion criteria
- Medications that might significantly interfere with the effects of the study medications
- Cognitive dysfunction that could interfere with study participation
- Alcohol or substance use disorder
- Any lifetime history of hallucinogen use disorder
- Regular use or misuse of hallucinogens
- History of intolerance to perceptual altering drugs
- Significant blood pressure problems
- Pregnancy or currently breast feeding (lactation)
- Any unstable medical conditions
- Significant cardiovascular disease
- Significantly abnormal laboratory test results
- History of serotonin syndrome Some Exclusion criteria for MDD subjects:
- Current primary psychiatric disorder other than MDD
- Medically significant condition rendering unsuitability for the study Some Exclusion criteria for healthy controls:
- No current DSM-V psychiatric disorder, excluding nicotine and caffeine use disorder
- No family history of serious mental illness (e.g., schizophrenia, bipolar disorder) Some Inclusion criteria for healthy controls:
- No current DSM-5 psychiatric disorder, excluding nicotine and caffeine use disorder
- No lifetime use of psychiatric medication \>3 months (proxy for psychiatric disorders)
Where
- West Haven, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations