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

Официальное название

Phase 1 Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Safety of Physiological indices [Срок оценки: 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.]
• Psychedelic Effects [Срок оценки: From start Test Day Time points (Minutes): -60, +30, +120.]
• Psychotomimetic Effects [Срок оценки: Test Day Time points (Minutes): -60, +30, +120]
• Anxiety [Срок оценки: Test Day Time points (Minutes): -60, +30, +120]
• Depression [Срок оценки: From start of test day (-60), +30, and +120.]
• Intensity of the Experience [Срок оценки: Test Day Time points (Minutes): +150 - +180]
• Drug Reinforcing Effects [Срок оценки: Test Day Time points (Minutes): +120]
• Tolerability of Overt Adverse Effects [Срок оценки: Test Day Time points (Minutes): -60, +30, +120, 180 (end of test day)]
• Electrophysiological [Срок оценки: Resting State EEG: Will be collected the day after each dosing session. [Time Frame: -60 minutes before DMT administration until +180 minutes after DMT administration].]

Вторичные конечные точки (5)

• Expectancy Effects [Срок оценки: Subjects will be tested for expectancy effects at screening, and before each dosing session.]
• Adequacy of blinding [Срок оценки: Time Frame: 0; immediately after DMT administration, and +180 minutes at the end of the study]
• Blood [Срок оценки: Blood sample measurements will be repeated approximately 0, 20, 30, and 60 minutes after drug administration]
• Changes in personality domains (NEO personality inventory) [Срок оценки: [Time Frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration]]
• Psychological Flexibility [Срок оценки: Time Frame: +180 minutes after DMT administration]

Критерии участия

Some Common 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine, — West Haven

Идентификаторы

NCT: NCT06671977 · 2000034770

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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