Health TrialsbyHealthPanel

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

ConditionsMajor Depression DisorderDepression
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorDeepak C. D'Souza

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 5 treatment groups
Group A: 10 mg slow intravenous push (bolus) over 5 minutes and then 0.01 mg/kg/min for 55 minutesActive comparator 1 intervention
Group B: 14 mg slow intravenous push (bolus) over 5 minutes and then 0.015 mg/kg/min for 55 minutes.Active comparator 1 intervention
Group C: 0.5 mg over 5 minutes and then 2 mg over and 55 minutesActive comparator 1 intervention
Group D: PlaceboPlacebo comparator 4 interventions
Group E: 0.1 mg slow intravenous push (bolus) over 5 minutes and then I mg over 55 minutesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety of Physiological indices

Pulse oximetry will be measured continuously.

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.
2

Psychedelic Effects

The 30-item revised Mystical Experience Questionnaire (MEQ30) will be used to measure mystical/psychedelic experiences associated with drugs like psilocybin

Time frame
From start Test Day Time points (Minutes): -60, +30, +120.
3

Psychotomimetic Effects

To capture the effects of DMT/THC/placebo on perception, thought, and sensory processing, participants will be measured using the Psychotomimetic States Inventory

Time frame
Test Day Time points (Minutes): -60, +30, +120
4

Anxiety

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.

Time frame
Test Day Time points (Minutes): -60, +30, +120

Secondary outcomes

1

Expectancy Effects

Time frame
Subjects will be tested for expectancy effects at screening, and before each dosing session.
2

Adequacy of blinding

Subjects will be asked to guess their treatment assignment, the degree of certainty of their guess and the reason for their guess both immediately after the psychedelic dosing session(s) and at the end of the study. Either the James' blinding index (BI) or Bang's BI, will be used to measure the adequacy of the blind.

Time frame
Time Frame: 0; immediately after DMT administration, and +180 minutes at the end of the study
3

Blood

Time frame
Blood sample measurements will be repeated approximately 0, 20, 30, and 60 minutes after drug administration
4

Changes in personality domains (NEO personality inventory)

Time frame
[Time Frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration]

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Deepak C. D'Souza

Lead sponsor

Yale University

Sponsor institution

Source ClinicalTrials.gov
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