Table 2.
Overview of participants, completed doses, adverse events, and data included in the analyses. On one occasion, the participant requested to terminate the continuous infusion at minute 26. Parameters for the doses are given in Table 1.
Participant | Doses received | Adverse events | Notes |
---|---|---|---|
1 | 1, 2, 3 | Received an initial pilot dose of 1.5 mg bolus plus 0.2 mg/min of DMT (not reported here) and thus completed the four doses the protocol allowed and could not receive Dose 4 | |
2 | 1, 2, 3 | Dose 3: anxiety with chest discomfort (nothing abnormal was found on an ECG performed immediately after the infusion) | Dose 3 terminated at minute 26 upon request – all data up to minute 26 included in analysis |
3 | 1, 2, 3 | Dose 1 was repeated due to infusion line blocking on the first attempt and thus completed the four doses the protocol allowed and could not receive Dose 4 | |
4 | 1, 2, 3, 4 | ||
5 | 1, 2 | Dropped out after Dose 2 due to personal reasons not related to adverse events | |
6 | 1 | Infusion line blocked at minute 27 and 29 on Dose 1 – all data up to minute 26 included in analysis Dropped out after Dose 1 due to personal reasons not related to adverse events |
|
7 | 2, 3, 4 | ||
8 | 2, 3, 4 | Dose 4: slight nausea | |
9 | 2, 3, 4 | Infusion line blocked on Dose 4 – excluded from analysis | |
10 | 2, 3, 4 | ||
11 | 2, 3, 4 |
Note: Participant 2 experienced anxiety and chest pains on Dose 3 starting from approx. minute 20 and requested to terminate the infusion at minute 26. Anxiety and chest pains subsided within 10 min of the end of infusion, and follow-up examinations (ECG, blood tests) did not show any abnormalities, suggesting that chest pains were of a psychogenic nature. Dose 1 was omitted for participants 7–11 to prioritise higher doses (Dose 2, 3, 4).