Phase 1 Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans
Deepak C. D'Souza
Summary
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
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugDMT-Medium Dose
14 mg slow intravenous push (bolus) over 5 minutes and then 0.015 mg/kg/min for 55 minutes.
- DrugDMT-Low Dose
10 mg slow intravenous push (bolus) over 5 minutes and then 0.01 mg/kg/min for 55 minutes
- DrugTHC-Medium Dose
0.5 mg over 5 minutes and then 2 mg over and 55 minutes
- DrugTHC-Low Dose
0.1 mg slow intravenous push (bolus) over 5 minutes and then I mg over 55 minutes
Location
- Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine,West Haven, Connecticut