Table 1.
Parameter | Mean (SD) E max | p value from pairwise comparison | ||||
---|---|---|---|---|---|---|
OXY | sOXN | Placebo | OXY vs sOXN | sOXN vs Placebo | OXY vs Placebo | |
Overall Drug Likinga | 79.5 (26.7) | 49.5 (18.5) | 46.0 (15.0) | 0.001 | 0.46 | <0.001 |
Take Drug Againa | 82.0 (28.4) | 37.0 (29.0) | 34.5 (24.2) | <0.001 | 0.42 | <0.001 |
Good Effects | 94.0 (21.2) | 20.0 (34.9) | 2.7 (11.7) | <0.001 | 0.07 | <0.001 |
High | 94.6 (21.3) | 19.6 (33.4) | 2.9 (11.7) | <0.001 | 0.05 | <0.001 |
Bad Effectsb | 11.5 (22.4) | 7.5 (21.2) | 2.9 (12.3) | – | – | – |
Feeling Sickb | 10.3 (23.0) | 7.5 (23.2) | 3.0 (10.8) | – | – | – |
Drowsiness/Alertnessc | 32.1 (25.1) | 47.3 (23.4) | 47.2 (25.0) | <0.001 | 0.91 | 0.04 |
aEnd-of-treatment assessments
bTreatment differences were not assessed because overall treatment effect was not significant
c E min values used for Drowsiness/Alertness
E max maximum effect, E min minimum effect, OXY oxycodone 0.07 mg/kg, sOXN simulated oxycodone 0.07 mg/kg + naloxone 0.035 mg/kg, SD standard deviation, VAS visual analog scale [either unipolar (i.e., 0 = no effect) including High, Good Effects, Bad Effects or bipolar (i.e., 50 = neutral response) including Overall Drug Liking, Take Drug Again, and Drowsiness/Alertness]