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.
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
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