Systolic and diastolic blood pressure will be measured before and several times after the administration of DMT on each test day.
Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans
0.1 mg/kg Dimethyltryptamine (DMT) (DRUG)0.1 mg/kg DMT
0.3 mg/kg Dimethyltryptamine (DMT) (DRUG)0.3 mg/kg DMT
Condition or Disease
- Major Depressive Disorder
|Status:||Active, not recruiting|
|Study results:||No Results Available|
|Age:||21 Years to 65 Years|
Clinical Trial Dates
|Start date:||Mar 17, 2021||ACTUAL|
|Primary Completion:||Dec 01, 2023||ESTIMATED|
|Completion Date:||Jun 01, 2024||ESTIMATED|
|Study First Posted:||Jan 15, 2021||ACTUAL|
|Last Updated:||Feb 28, 2023|
0.1 mg/kg DMT administered intravenously
0.3 mg/kg DMT administered intravenously
|Age Groups:||Adult / Older Adult|
* Medically healthy
* Psychiatrically healthy
Healthy controls exclusion criteria:
* Unstable medical conditions
* Psychiatric illness
Depression inclusion criteria:
* Medically healthy
* Diagnosis of major depressive disorder
Depression exclusion criteria:
-Unstable medical conditions
Heart rate will be measured before and several times after the administration of DMT on each test day.
The modified Altered States of Consciousness Rating Scale (ASC) will be used to assess drug-induced altered states of consciousness before and several times after drug administration. This is a 23-item subjective rating scale that will be completed using a visual analog scale format. Questions are scored 0 to 100 each; higher numbers indicate greater psychedelic effects.
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 the net anxiety produced by DMT. This will be collected before and several times after DMT administration.
Subjects will be asked to answer questions such as (1) How likely are you to use this drug? and (2) How much are you willing to pay for this experience? using a visual analog scale.
Overall tolerability will be assessed using a visual analog scale that subjects will be asked to score from 0 (well tolerated) to 100 (intolerable) to capture the net tolerability of DMT.