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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests the safety and effects of dimethyltryptamine (DMT) in adults with depression and healthy adults. It looks at changes in depression, mood, and brain activity using EEG, a test that records electrical signals in the brain.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults ages 21–65 of any sex, with a body mass index (BMI, a measure of weight compared with height) of 18–35.
  • Must avoid medicines not approved by the study doctor, street drugs, and alcohol, and have a negative urine drug test.
  • Must avoid smoking during each test session and not drive to or from testing.
  • Sexually active women who could become pregnant must use effective birth control.
  • People in the depression group must have major depressive disorder (MDD) and an unsatisfactory response to antidepressant medicines.
  • The depression group needs support from their mental health clinician and must allow the study team to contact that clinician. The listing gives conflicting rules about being in treatment; ask the study team to clarify.
  • Healthy volunteers must have no current mental health disorder, except nicotine or caffeine use disorder, and no family history of serious mental illness, such as schizophrenia or bipolar disorder.
  • Healthy volunteers must not have taken psychiatric medicine for more than 3 months in their lifetime.

Who can't join

  • Taking medicines that could strongly affect how the study drugs work.
  • Problems with thinking or memory that could make study participation difficult.
  • Alcohol or drug use disorder, or any past hallucinogen use disorder. Hallucinogens are drugs that change what you see, hear, or feel.
  • Regular use or misuse of hallucinogens, or a history of not tolerating drugs that change your senses.
  • Major blood pressure problems, serious heart or blood vessel disease, or any unstable medical condition.
  • Pregnancy or breastfeeding.
  • Major abnormal lab test results or a history of serotonin syndrome, a serious reaction linked to too much serotonin in the body.
  • For the depression group: a main mental health disorder other than MDD, or a medical condition that makes participation unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Some Common Inclusion Criteria: 1. Males and females 2. Age 21 to 65 years 3. Body mass index between 18-35 kg/m2 4. Willing to refrain from taking any medications not approved by the study physician 5. Willing to refrain from using street drugs and alcohol 6. Negative urine drug screen 7. Willing and able to abstain from smoking throughout each test session 8. Women who are of child-bearing potential (WOCBP) and sexually active must be willing to practice an effective means of birth control 9. Willing not to drive to and from the testing session Some Inclusion Criteria for Subjects with MDD: 1. Diagnosed with Major Depressive Disorder (MDD) 2. Unsatisfactory response to antidepressants 3. Engaged in treatment for depression with a clinician and willing to continue treatment for the duration of the study 4. Not engaged in treatment 5. Consent to allow the research team to communicate with mental health provider. 6. 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: 1. Medications that might significantly interfere with the effects of the study medications 2. Cognitive dysfunction that could interfere with study participation 3. Alcohol or substance use disorder 4. Any lifetime history of hallucinogen use disorder 5. Regular use or misuse of hallucinogens 6. History of intolerance to perceptual altering drugs 7. Significant blood pressure problems 8. Pregnancy or currently breast feeding (lactation) 9. Any unstable medical conditions 10. Significant cardiovascular disease 11. Significantly abnormal laboratory test results 12. History of serotonin syndrome Some Exclusion criteria for MDD subjects: 1. Current primary psychiatric disorder other than MDD 2. Medically significant condition rendering unsuitability for the study Some Exclusion criteria for healthy controls: 1. No current DSM-V psychiatric disorder, excluding nicotine and caffeine use disorder 2. No family history of serious mental illness (e.g., schizophrenia, bipolar disorder) Some Inclusion criteria for healthy controls: 1. No current DSM-5 psychiatric disorder, excluding nicotine and caffeine use disorder 2. No lifetime use of psychiatric medication \>3 months (proxy for psychiatric disorders)

Study sites (1)

CT