Table 4 Treatment-emergent adverse events and expected reactions during two MDMA Sessions and seven days following.
Placebo (n = 5) | MDMA (n = 13) | Total (n = 18) | |
|---|---|---|---|
Top reactions during experimental sessions, no. (%)a | |||
Anxiety | 0 | 3 (23.1) | 3 (16.7) |
Dry mouth | 1 (20.0) | 9 (69.2) | 10 (55.6) |
Headache | 1 (20.0) | 8 (61.5) | 9 (50.0) |
Insomnia | 1 (20.0) | 2 (15.4) | 3 (16.7) |
Jaw clenching, tight jaw | 1 (20.0) | 11 (84.6) | 12 (66.7) |
Lack of appetite | 0 | 4 (30.8) | 4 (22.2) |
Nausea | 1 (20.0) | 3 (23.1) | 4 (22.2) |
Perspiration | 0 | 9 (69.2) | 9 (50.0) |
Sensitivity to cold | 1 (20.0) | 2 (15.4) | 3 (16.7) |
Thirst | 2 (40.0) | 11 (84.6) | 13 (72.2) |
Top reactions during 7 days of contact, no. (%)a | |||
Anxiety | 2 (40.0) | 8 (61.5) | 10 (55.6) |
Drowsiness | 1 (20.0) | 6 (46.2) | 7 (38.9) |
Dry mouth | 0 | 3 (23.1) | 3 (16.7) |
Fatigue | 3 (60.0) | 12 (92.3) | 15 (83.3) |
Increased irritability | 1 (33.3) | 2 (15.4) | 3 (16.7) |
Insomnia | 2 (40.0) | 9 (69.2) | 11 (61.1) |
Jaw clenching, tight jaw | 1 (20.0) | 8 (61.5) | 9 (50.0) |
Lack of appetite | 0 | 4 (30.8) | 4 (22.2) |
Low mood | 3 (60.0) | 8 (61.5) | 11 (61.1) |
Nausea | 1 (20.0) | 6 (46.2) | 7 (38.9) |
Need more sleep | 2 (40.0) | 12 (92.3) | 14 (77.8) |
Psychiatric TEAEs, no. (%)b | |||
Anxiety | 0 | 1 (7.7) | 1 (5.6) |
Depressed mood | 0 | 1 (7.7) | 1 (5.6) |
Depression | 0 | 1 (7.7) | 1 (5.6) |
Dissociation | 0 | 1 (7.7) | 1 (5.6) |
Insomnia | 1 (20.0) | 2 (15.4) | 3 (16.7) |
