Actively Recruiting
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
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 21 to 65 years
- Body mass index between 18 and 35 kg/m2
- English speaking
- Able to provide informed consent
- Willing to avoid any medications not approved by the study doctor
- Willing to avoid street drugs and alcohol the day before, day of, and day after each test session
- Negative urine drug screen on each test day
- Willing and able to abstain from smoking during each test session
- Women of child-bearing potential must use effective birth control
- Willing not to drive to and from testing sessions
- For those with Major Depressive Disorder (MDD): diagnosed with MDD and currently experiencing a moderate to severe episode (HAMD score ≥17)
- Unsatisfactory response or intolerance to at least one antidepressant trial in current episode
- Engaged in treatment for depression and willing to continue during study
- Those not in treatment must engage in treatment to participate
- Consent to allow research team to contact primary mental health provider
You will not qualify if you...
- Current significant risk for suicide or aggressive behavior
- History or current psychotic disorders or psychotic symptoms
- Taking antidepressant medications or others that affect 5HT2A receptors (except low-dose sleep meds)
- Use of over-the-counter products like 5-hydroxytryptophan or St. John's wort
- Cognitive dysfunction interfering with participation
- Recent alcohol or substance use disorder (excluding caffeine and nicotine)
- Excessive alcohol consumption (≥7 drinks/week females, ≥14 drinks/week males)
- Lifetime hallucinogen use disorder
- Regular use or misuse of serotonergic hallucinogens
- History of intolerance to perception-altering drugs
- Low blood pressure or orthostatic hypotension
- Pregnancy or breastfeeding
- Unstable medical conditions including uncontrolled hypertension, diabetes, renal/hepatic failure, or seizure disorder
- Participation in other clinical trials within past month
- Physical conditions or lab abnormalities posing risk or interfering with results
- First-degree relatives with psychosis
- IQ below 80
- For depressed subjects: other primary psychiatric disorders, medically significant conditions, or history of mania
- For healthy controls: current psychiatric disorder, use of psychiatric medication over 3 months lifetime, or family history of serious mental illness
AI-Screening
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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
CONTACT
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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