Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Deepak C. D'Souza
Study ID
NCT06671977
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • DMT-Medium Dose — DRUG
    14 mg slow intravenous push (bolus) over 5 minutes and then 0.015 mg/kg/min for 55 minutes.
  • DMT-Low Dose — DRUG
    10 mg slow intravenous push (bolus) over 5 minutes and then 0.01 mg/kg/min for 55 minutes
  • THC-Medium Dose — DRUG
    0.5 mg over 5 minutes and then 2 mg over and 55 minutes
  • THC-Low Dose — DRUG
    0.1 mg slow intravenous push (bolus) over 5 minutes and then I mg over 55 minutes

Study Details

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.

Key Dates

Start date
Mar 14, 2025
Status verified
May 2025
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: 10 mg slow intravenous push (bolus) over 5 minutes and then 0.01 mg/kg/min for 55 minutes
    Low dose DMT
  • Active Comparator: 14 mg slow intravenous push (bolus) over 5 minutes and then 0.015 mg/kg/min for 55 minutes.
    Medium Dose DMT
  • Active Comparator: 0.5 mg over 5 minutes and then 2 mg over and 55 minutes
    THC-Medium Dose
  • Placebo Comparator: Placebo
  • Active Comparator: 0.1 mg slow intravenous push (bolus) over 5 minutes and then I mg over 55 minutes
    Low Dose THC

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine,West HavenConnecticut06516
Deepak C D'Souza, MD
[email protected]
203-932-5711

Find similar trials in West Haven, CT

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine· West Haven, CT

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