Actively Recruiting
Phase 1 Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans
Led by Deepak C. D'Souza · Updated on 2025-05-02
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, effects on brain activity, and potential benefits of dimethyltryptamine (DMT) in people with depression as well as healthy volunteers. This phase 1 trial aims to see if DMT can reduce depression symptoms and cause changes in brain plasticity, measured by EEG and mood assessments. The study compares these effects between depressed and healthy participants. Participants receive different doses of DMT or THC through slow intravenous infusions over about an hour. There are low and medium dose groups for both DMT and THC, plus a placebo group. The dosing sessions include careful monitoring of physiological responses and brain activity. The study uses a triple-blind, randomized design to evaluate safety and tolerability. Participants undergo blood pressure, heart rate, and EEG monitoring before, during, and after dosing. Mood and psychological effects are measured at multiple time points using psychometric tests. Blood samples and personality assessments are collected. The study also tracks drug effects, tolerability, and expectancy. Participation lasts through several dosing sessions with follow-up evaluations of brain and mood changes.
CONDITIONS
Brief Title
Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 21 to 65 years
- Body mass index between 18-35 kg/m2
- English speaking and able to provide informed consent
- Willing to avoid unapproved medications, street drugs, and alcohol around test sessions
- Negative urine drug screen on test days
- Abstain from smoking during test sessions
- Women of child-bearing potential must use effective birth control
- Willing not to drive to and from testing sessions
- Diagnosed with moderate to severe major depressive disorder (score ≥17 on HAMD) currently experiencing an episode
- Unsatisfactory response or intolerance to at least one antidepressant trial during current episode
- Engaged in or willing to engage in treatment for depression throughout the study
- Consent to allow research team to contact primary mental health provider
- Healthy controls must have no current DSM-5 psychiatric disorder except nicotine/caffeine use disorder
- Healthy controls must have no significant psychiatric medication use or family history of serious mental illness
You will not qualify if you...
- Recent significant risk of suicide or aggressive behavior
- Current or past history of psychotic disorders or psychotic symptoms
- Currently taking antidepressants or medications altering 5HT2A agonist effects (exceptions for low-dose sleep meds)
- Use of over the counter products like 5-HTP or St. John's wort
- Cognitive dysfunction interfering with participation
- Recent alcohol or substance use disorder (excluding caffeine/nicotine)
- Alcohol consumption exceeding NIAAA guidelines
- History of hallucinogen use disorder or regular use of serotonergic hallucinogens
- History of intolerance to perception-altering drugs (including DMT, THC, ketamine, etc.)
- Hypotension or orthostatic hypotension
- Pregnancy or breastfeeding
- Unstable medical conditions like uncontrolled hypertension, diabetes, or organ failure
- Recent participation in another investigational drug or device trial
- Physical conditions or abnormal labs posing risk or interfering with results
- First-degree relatives with psychosis history
- IQ below 80
- Current primary psychiatric disorders other than MDD in depressed subjects
- History of mania
- Healthy controls with current psychiatric disorders or significant psychiatric medication use
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Each dosing session lasts approximately 1 hour, with multiple sessions scheduled according to the crossover design.
Participants receive different doses of DMT or THC administered intravenously in a crossover design to assess safety, tolerability, and physiological effects.
Multiple dosing visits with assessments before, during, and after administration
Duration - Day after each dosing session
Participants undergo assessments including resting state EEG the day after each dosing session to monitor electrophysiological effects and safety.
1 follow-up visit per dosing session (in-person)
Trial Site Locations
Total: 1 location
1
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine,
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
D
Deepak C D'Souza, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
5
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