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

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)