Table 1 Demographics and acute adverse events reported with a relationship to the drug (placebo and 5-MeO-DMT) sublingual administration.
DEMOGRAPHICS | Placebo Group (n = 9) | 6 mg 5-MeO-DMT Group (n = 9) | 9 mg 5-MeO-DMT Group (n = 9) | 12 mg 5-MeO-DMT Group (n = 9) |
|---|---|---|---|---|
Gender | ||||
Male | 4 | 4 | 3 | 4 |
Female | 5 | 5 | 6 | 5 |
Age, years | ||||
Mean (SD) | 53 (8) | 58 (12) | 49 (6) | 55 (9) |
Range | 46–66 | 41–72 | 41–61 | 46–76 |
Depression and/or anxiety levels at baseline (Week 0) | ||||
BDI, Mean (SD) | 21 (7) | 24 (4) | 21 (5) | 23 (15) |
STAI-S, Mean (SD) | 29 (7) | 31 (5) | 29 (9) | 26 (16) |
STAI-T, Mean (SD) | 33 (8) | 32 (5) | 35 (10) | 28 (15) |
Body mass index (kg/m2) | ||||
Mean (SD), Week 0 | 27.3 (1.8) | 26.4 (2.8) | 25.4 (2.3) | 25.8 (2.5) |
Mean (SD), Week 5 | 26.9 (1.9) | 25.8 (2.7) | 25.7 (1.8) | 25.3 (2.0) |
Acute adverse events | ||||
Gastrointestinal Disorders | ||||
Abdominal discomfort | 0 | 0 | 0 | 0 |
Nausea | 0 | 0 | 0 | 1 |
General disorders | ||||
Feeling abnormal | 0 | 0 | 1 | 2 |
Muscle discomfort | 0 | 0 | 0 | 2 |
Sensation of Heart rate increase | 0 | 1 | 0 | 1 |
Fatigue | 0 | 0 | 0 | 1 |
Cold sweat | 0 | 0 | 0 | 0 |
Fever | 0 | 0 | 0 | 0 |
Nervous system disorders | ||||
Dizziness | 1 | 0 | 0 | 2 |
Headache | 1 | 0 | 1 | 0 |
Paraesthesia | 0 | 0 | 0 | 0 |
Sensory disturbance | 0 | 0 | 0 | 3 |
Psychiatric disorders | ||||
Hallucination | 0 | 0 | 0 | 0 |
Anxiety | 0 | 0 | 0 | 0 |
Sleep disorder | 1 | 1 | 0 | 0 |
Euphoric mood | 0 | 0 | 0 | 0 |
Total adverse events | 3 | 2 | 2 | 12 |
