Table 2.
Comparison of Key Abuse Liability Parameters—VAS Measures (Completer Set, n = 39)
| Comparison | Drug Liking (at This Moment) | Drug Liking Overall | Take Drug Again | Effects — Good | Effects — Bad | Effects — Any | Agitation/Relaxation | Alertness/Drowsiness | PAL Total Errors | |
|---|---|---|---|---|---|---|---|---|---|---|
| Absolute values, mean (SD) | ||||||||||
| Emax | ||||||||||
| PBO | 53.1 (8.1) | 52.8 (14.1) | 17.1 (28.2) | 6.9 (19.0) | 0.2 (0.8) | 6.6 (18.0) | — | — | 16.7 (17.5) | |
| RMZ 5 | 77.7 (14.1) | 61.8 (17.2) | 36.9 (35.5) | 64.5 (24.1) | 15.0 (20.7) | 67.0 (22.3) | — | — | 27.1 (21.0) | |
| RMZ 10 | 79.8 (15.1) | 67.3 (18.7) | 49.2 (34.0) | 70.9 (22.8) | 30.7 (34.4) | 73.1 (18.8) | — | — | 36.2 (21.5) | |
| MDZ 2.5 | 78.6 (14.0) | 67.3 (17.2) | 56.4 (33.2) | 65.6 (24.7) | 12.9 (21.9) | 67.2 (22.9) | — | — | 36.7 (20.7) | |
| MDZ 5 | 81.5 (11.7) | 69.3 (16.2) | 58.5 (32.4) | 72.9 (20.6) | 27.9 (33.4) | 76.1 (18.8) | — | — | 55.4 (14.5) | |
| Emin | ||||||||||
| PBO | 45.9 (13.4) | 51.8 (13.1) | — | — | — | — | 41.1 (14.0) | 49.1 (16.3) | — | |
| RMZ 5 | 43.8 (15.2) | 57.2 (16.8) | — | — | — | — | 18.7 (12.4) | 24.2 (15.8) | — | |
| RMZ 10 | 42.4 (15.3) | 58.5 (20.6) | — | — | — | — | 15.1 (11.8) | 16.4 (13.4) | — | |
| MDZ 2.5 | 46.2 (11.3) | 63.9 (18.5) | — | — | — | — | 16.7 (11.5) | 18.1 (13.9) | — | |
| MDZ 5 | 44.7 (13.8) | 62.3 (15.5) | — | — | — | — | 12.6 (9.9) | 15.4 (12.4) | — | |
| TA_AUE | ||||||||||
| PBO | −6.9 (60.4) | — | — | 6.3 (21.5) | 0.1 (0.3) | 5.7 (19.8) | 6.3 (77.6) | 19.4 (124.5) | 12.1 (95.0) | |
| RMZ 5 | 22.2 (66.4) | — | — | 55.0 (87.2) | 6.1 (15.3) | 50.3 (67.3) | −23.1 (61.0) | −13.4 (119.7) | −6.6 (76.8) | |
| RMZ 10 | 28.3 (57.7) | — | — | 71.0 (86.2) | 13.1 (36.9) | 72.4 (84.7) | −22.9 (37.1) | −29.9 (67.7) | 21.1 (82.6) | |
| MDZ 2.5 | 41.5 (64.0) | — | — | 100.0 (110.3) | 11.1 (28.7) | 95.5 (90.5) | −34.5 (63.3) | −62.7 (86.3) | 48.6 (106.2) | |
| MDZ 5 | 48.4 (52.3) | — | — | 112.9 (82.3) | 20.5 (33.8) | 119.9 (89.6) | −65.2 (58.2) | −66.7 (103.9) | 51.1 (55.8) | |
| Difference in LS mean | ||||||||||
| Emax | — | |||||||||
| MDZ 2.5 | vs PBO | 25.53 a | 14.45 a | 39.17 a | 58.61 a | 12.66 a | 60.54 a | — | — | 19.9 a |
| MDZ 5 | vs PBO | 28.32 a | 16.35 a | 41.09 a | 65.71 a | 27.75 a | 69.24 a | — | — | 38.6 a |
| RMZ 5 | vs PBO | 24.57 a | 8.97 a | 19.81 a | 57.39 a | 14.57 a | 60.32 a | — | — | 10.2 a |
| RMZ 10 | vs PBO | 26.69 a | 14.43 a | 32.09 a | 63.83 a | 30.35 a | 66.44 a | — | — | 19.3 a |
| RMZ 5 | vs MDZ 2.5 | −0.95 | −5.48 | −19.35 a | −1.23 | 1.91 | −0.22 | — | — | −9.6 a |
| RMZ 10 | vs MDZ 5 | −1.63 | −1.92 | −9.01 | −1.88 | 2.60 | −2.80 | — | — | −19.4 a |
| Emin | ||||||||||
| MDZ 2.5 | vs PBO | 0.22 | 11.99 a | — | — | — | — | −24.31 a | −30.87 a | — |
| MDZ 5 | vs PBO | −1.33 | 10.34 a | — | — | — | — | −28.46 a | −33.55 a | — |
| RMZ 5 | vs PBO | −2.13 | 5.36 | — | — | — | — | −22.40 a | −24.63 a | — |
| RMZ 10 | vs PBO | −3.65 | 6.62 a | — | — | — | — | −26.02 a | −32.56 a | — |
| RMZ 5 | vs MDZ 2.5 | −2.35 | −6.63 a | − | — | — | — | 1.91 | 6.23 a | — |
| RMZ 10 | vs MDZ 5 | −2.32 | −3.72 | — | — | — | — | 2.45 | 0.99 | — |
| TA_AUE | ||||||||||
| MDZ 2.5 | vs PBO | 48.47 a | — | — | 93.83 a | 10.95 a | 89.95 a | −41.21 a | −81.53 a | 36.1 |
| MDZ 5 | vs PBO | 55.20 a | — | — | 106.30 a | 20.48 a | 114.01 a | −71.51 a | −86.16 a | 38.6 a |
| RMZ 5 | vs PBO | 29.08 a | — | — | 48.59 a | 5.96 | 44.55 a | −29.51 a | −32.36 | −19.9 |
| RMZ 10 | vs PBO | 35.20 a | — | — | 64.89 a | 12.97 a | 66.96 a | −29.12 a | −48.66 a | 7.9 |
| RMZ 5 | vs MDZ 2.5 | −19.39 | — | — | −45.24 a | −4.99 | −45.50 a | 11.70 | 49.17 a | −55.9 a |
| RMZ 10 | vs MDZ 5 | −20.00 | — | — | −41.41 a | −7.51 | −47.05 a | 42.39 a | 37.50 | −30.7 |
Emax, maximum observed effect; Emin, minimum observed effect; MDZ, midazolam; PAL, paired associates learning; PBO, placebo; RMZ, remimazolam; TA, time‐averaged area under the effect curve; VAS, visual analog scale.
a
P < .05.