Table 3.
Average change from pre-dose score*.
| BXCL501 Dose Condition |
|||||||
|---|---|---|---|---|---|---|---|
| 30 ug (N=17) | 60 ug (N=17) | 90 ug (N=21) | 120 ug (N=19) | 180 ug (N=21) | 240 ug (N=15) | Placebo (N=25) | |
| n (SD) | n (SD) | n (SD) | n (SD) | n (SD) | n (SD) | n (SD) | |
|
| |||||||
| Short Opiate Withdrawal Scale (SOWS) | |||||||
| Feeling Sick | |||||||
| Day 6 | −0.21 (0.708) | 0.22 (1.048) | 0.00 (0.397) | 0.03 (0.612) | 0.19 (0.622) | 0.03 (0.915) | −0.04 (0.576) |
| Day 7 | −0.19 (0.663) | −0.04 (1.177) | 0.14 (1.096) | 0.08 (0.449) | 0.22 (0.515) | −0.33 (0.685) | 0.14 (0.819) |
| Day 8 | −0.15 (0.826) | −0.14 (0.378) | 0.28 (0.912) | 0.20 (0.350) | −0.47 (0.741) | −0.20 (0.483) | 0.31 (0.805) |
| Day 9 | 0.00 (0.000) | 0.07 (0.673) | 0.20 (1.059) | −0.20 (0.422) | −0.25 (0.691) | −0.31 (0.530) | 0.19 (0.843) |
| Day 10 | −0.29 (0.809) | 0.00 (0.316) | 0.00 (0.000) | −0.10 (0.211) | 0.00 (0.775) | −0.08 (0.585) | −0.13 (0.582) |
| Day 11 | 0.07 (0.189) | 0.30 (0.758) | 0.00 (0.000) | 0.06 (0.177) | −0.18 (0.513) | −0.08 (0.801) | 0.00 (0.289) |
| Day 12 | 0.00 (0.289) | 0.20 (0.274) | −0.33 (0.816) | 0.06 (0.177) | 0.14 (0.452) | −0.17 (0.683) | 0.50 (0.775) |
| Stomach Cramps | |||||||
| Day 6 | 0.00 (0.612) | 0.13 (0.885) | −0.13 (0.483) | −0.03 (0.676) | −0.10 (0.584) | −0.07 (0.863) | −0.28 (0.579) |
| Day 7 | −0.27 (0.725) | −0.13 (1.110) | −0.17 (0.786) | −0.10 (0.584) | 0.06 (0.727) | −0.33 (0.913) | 0.14 (0.795) |
| Day 8 | −0.08 (0.838) | 0.21 (0.636) | 0.00 (1.304) | 0.15 (0.530) | −0.38 (0.592) | −0.45 (0.798) | 0.12 (0.893) |
| Day 9 | −0.06 (0.167) | −0.21 (0.809) | 0.20 (0.675) | −0.10 (0.516) | −0.58 (0.793) | −0.63 (0.694) | 0.06 (0.623) |
| Day 10 | −0.14 (0.378) | −0.17 (0.753) | 0.07 (0.189) | −0.35 (0.474) | −0.45 (0.789) | −0.17 (0.683) | −0.19 (0.458) |
| Day 11 | −0.14 (0.244) | −0.10 (0.224) | −0.07 (0.189) | 0.13 (0.518) | −0.18 (0.603) | −0.67 (0.683) | −0.14 (0.378) |
| Day 12 | −0.07 (0.189) | 0.00 (0.354) | −0.17 (0.408) | −0.19 (0.372) | 0.00 (0.632) | −0.50 (0.632) | 0.17 (0.258) |
| Muscle Spasm/Twitching | |||||||
| Day 6 | 0.12 (0.332) | 0.06 (0.602) | −0.05 (0.456) | −0.24 (0.510) | −0.02 (0.558) | 0.13 (0.790) | −0.08 (0.553) |
| Day 7 | 0.04 (0.828) | 0.04 (0.753) | −0.17 (0.686) | 0.12 (0.583) | −0.25 (0.753) | −0.21 (1.137) | −0.18 (0.464) |
| Day 8 | 0.04 (0.877) | −0.29 (0.567) | 0.16 (0.507) | −0.20 (0.483) | −0.44 (0.655) | 0.05 (0.798) | −0.08 (0.572) |
| Day 9 | 0.00 (0.354) | −0.07 (0.189) | 0.00 (0.471) | −0.05 (0.284) | −0.38 (0.956) | −0.44 (0.623) | 0.19 (0.259) |
| Day 10 | −0.07 (0.673) | 0.00 (0.000) | −0.14 (0.244) | −0.15 (0.337) | 0.14 (1.027) | 0.00 (0.548) | −0.38 (0.582) |
| Day 11 | −0.14 (0.378) | 0.10 (0.224) | 0.07 (0.189) | −0.06 (0.177) | −0.23 (0.344) | −0.33 (0.606) | −0.07 (0.189) |
| Day 12 | −0.21 (0.267) | 0.00 (0.000) | −0.25 (0.880) | −0.06 (0.177) | −0.64 (0.595) | 0.00 (0.548) | 0.17 (0.683) |
| Feelings of Coldness | |||||||
| Day 6 | −0.21 (0.398) | 0.38 (0.885) | −0.20 (0.377) | −0.21 (0.561) | 0.12 (0.631) | 0.23 (0.942) | −0.06 (0.464) |
| Day 7 | −0.08 (0.449) | −0.67 (1.155) | −0.08 (0.845) | 0.12 (0.768) | 0.06 (0.704) | −0.21 (0.753) | 0.04 (0.692) |
| Day 8 | 0.23 (0.881) | −0.14 (0.852) | 0.00 (0.365) | −0.15 (0.709) | −0.19 (0.929) | −0.10 (0.394) | 0.23 (0.881) |
| Day 9 | −0.11 (0.220) | −0.36 (0.476) | −0.30 (0.483) | −0.05 (0.369) | −0.42 (0.597) | −0.94 (0.821) | −0.13 (0.354) |
| Day 10 | 0.00 (0.408) | 0.00 (0.000) | 0.07 (0.189) | 0.00 (0.527) | −0.50 (0.548) | −0.25 (0.880) | −0.31 (0.594) |
| Day 11 | −0.14 (0.378) | 0.20 (0.274) | −0.07 (0.189) | 0.19 (0.530) | −0.36 (0.674) | −0.25 (0.880) | −0.07 (0.345) |
| Day 12 | 0.00 (0.289) | −0.20 (0.447) | −0.17 (0.683) | 0.00 (0.463) | −0.27 (0.754) | −0.17 (0.683) | 0.08 (0.204) |
| Heart Pounding | |||||||
| Day 6 | −0.24 (0.589) | 0.16 (0.790) | −0.08 (0.766) | −0.33 (0.816) | −0.19 (0.402) | −0.10 (0.828) | −0.08 (0.607) |
| Day 7 | −0.12 (0.219) | −0.21 (0.582) | 0.00 (0.594) | 0.04 (0.431) | 0.16 (0.747) | −0.25 (1.055) | −0.04 (0.634) |
| Day 8 | −0.23 (0.927) | −0.07 (0.607) | 0.13 (0.847) | 0.00 (0.408) | −0.06 (0.704) | −0.05 (0.643) | 0.00 (0.500) |
| Day 9 | 0.06 (0.464) | −0.14 (0.476) | 0.10 (0.316) | −0.05 (0.284) | −0.04 (0.689) | −0.31 (0.753) | 0.00 (0.000) |
| Day 10 | −0.57 (0.838) | −0.33 (0.816) | −0.07 (0.189) | −0.15 (0.337) | −0.41 (0.701) | −0.25 (0.418) | 0.00 (0.000) |
| Day 11 | −0.14 (0.378) | −0.10 (0.224) | 0.00 (0.000) | −0.06 (0.177) | −0.27 (0.564) | −0.25 (0.689) | −0.14 (0.378) |
| Day 12 | 0.07 (0.450) | −0.20 (0.447) | −0.33 (0.816) | 0.00 (0.000) | −0.32 (0.462) | −0.33 (0.516) | −0.08 (0.376) |
| Muscle Tension | |||||||
| Day 6 | 0.00 (0.433) | 0.16 (0.926) | −0.05 (0.484) | −0.18 (0.628) | 0.02 (0.680) | 0.17 (0.748) | −0.12 (0.696) |
| Day 7 | −0.04 (0.380) | −0.04 (0.656) | 0.11 (0.654) | 0.00 (0.707) | 0.00 (0.447) | −0.21 (1.076) | −0.07 (0.852) |
| Day 8 | 0.15 (0.944) | 0.14 (0.852) | −0.06 (0.727) | −0.35 (0.626) | −0.16 (0.831) | 0.30 (0.422) | 0.00 (0.500) |
| Day 9 | 0.17 (0.354) | −0.07 (0.345) | 0.15 (0.474) | 0.05 (0.158) | 0.08 (0.793) | −0.56 (0.678) | 0.19 (0.372) |
| Day 10 | −0.07 (0.189) | −0.17 (0.408) | −0.07 (0.189) | −0.10 (0.211) | −0.41 (0.539) | −0.08 (0.492) | −0.31 (0.594) |
| Day 11 | −0.21 (0.267) | 0.10 (0.224) | 0.14 (0.244) | 0.06 (0.177) | 0.00 (0.387) | −0.67 (0.606) | −0.14 (0.627) |
| Day 12 | 0.00 (0.500) | −0.10 (0.224) | −0.42 (0.801) | −0.06 (0.177) | −0.36 (0.595) | 0.08 (0.376) | −0.42 (0.585) |
| Aches and Pains | |||||||
| Day 6 | −0.03 (0.483) | 0.03 (1.024) | −0.13 (0.604) | 0.03 (0.754) | 0.00 (0.671) | −0.03 (0.719) | −0.12 (0.650) |
| Day 7 | 0.08 (0.607) | 0.25 (0.452) | −0.22 (0.492) | −0.08 (0.400) | −0.13 (0.619) | −0.42 (1.145) | 0.14 (0.770) |
| Day 8 | 0.12 (1.024) | −0.21 (0.699) | −0.25 (0.658) | −0.10 (0.516) | −0.25 (0.658) | 0.25 (0.589) | −0.04 (1.108) |
| Day 9 | −0.28 (0.712) | −0.07 (0.345) | 0.00 (0.527) | 0.00 (0.236) | −0.21 (0.582) | −0.88 (0.744) | 0.19 (0.458) |
| Day 10 | −0.36 (0.378) | 0.00 (1.095) | 0.00 (0.289) | −0.15 (0.412) | −0.14 (0.745) | −0.50 (0.707) | −0.13 (0.354) |
| Day 11 | 0.07 (0.450) | 0.00 (0.354) | 0.07 (0.189) | −0.31 (0.458) | −0.27 (0.607) | −1.00 (0.548) | −0.14 (0.476) |
| Day 12 | 0.00 (0.408) | 0.00 (0.354) | −0.50 (0.775) | 0.06 (0.177) | −0.32 (0.643) | −0.33 (0.408) | −0.17 (0.683) |
| Yawning | |||||||
| Day 6 | 0.06 (0.166) | 0.22 (0.774) | 0.05 (0.320) | 0.00 (0.500) | −0.05 (0.350) | −0.07 (0.776) | 0.04 (0.498) |
| Day 7 | 0.19 (0.325) | −0.04 (0.722) | −0.11 (0.502) | −0.12 (0.300) | −0.06 (0.479) | −0.21 (1.252) | −0.14 (0.691) |
| Day 8 | 0.00 (1.307) | 0.00 (0.764) | −0.06 (0.704) | 0.10 (0.211) | 0.16 (0.651) | −0.15 (0.818) | −0.04 (0.721) |
| Day 9 | −0.28 (0.618) | 0.00 (0.289) | −0.15 (0.337) | 0.00 (0.236) | −0.08 (0.557) | −0.81 (0.704) | −0.13 (0.231) |
| Day 10 | −0.07 (0.189) | −0.17 (0.258) | −0.07 (0.189) | 0.00 (0.236) | −0.23 (0.564) | −0.33 (0.753) | −0.31 (0.594) |
| Day 11 | 0.00 (0.289) | 0.00 (0.000) | 0.00 (0.000) | 0.00 (0.000) | −0.09 (0.539) | −0.50 (0.775) | −0.43 (0.535) |
| Day 12 | −0.07 (0.345) | −0.30 (0.671) | −0.25 (0.418) | 0.06 (0.417) | −0.18 (0.337) | −0.42 (0.585) | 0.17 (0.258) |
| Runny Eyes | |||||||
| Day 6 | 0.15 (0.386) | 0.00 (0.632) | 0.05 (0.394) | −0.03 (0.456) | 0.00 (0.524) | 0.00 (0.681) | 0.04 (0.320) |
| Day 7 | 0.00 (0.500) | 0.13 (1.025) | 0.36 (0.637) | 0.00 (0.677) | 0.19 (0.443) | 0.25 (1.138) | 0.25 (0.643) |
| Day 8 | 0.15 (0.658) | −0.07 (0.450) | 0.31 (0.512) | 0.00 (0.408) | 0.28 (0.515) | −0.15 (0.474) | 0.31 (0.480) |
| Day 9 | 0.00 (0.433) | −0.07 (0.673) | 0.20 (0.675) | 0.10 (0.211) | 0.08 (0.469) | −0.31 (0.704) | −0.06 (0.563) |
| Day 10 | 0.21 (0.636) | −0.17 (0.258) | 0.14 (0.244) | 0.00 (0.408) | −0.27 (0.754) | −0.08 (0.376) | −0.31 (0.651) |
| Day 11 | −0.29 (0.488) | −0.20 (0.274) | −0.14 (0.244) | 0.00 (0.000) | −0.05 (0.611) | −0.58 (0.665) | −0.29 (0.567) |
| Day 12 | 0.00 (0.289) | −0.20 (0.447) | −0.17 (0.408) | 0.00 (0.000) | 0.18 (0.462) | −0.08 (0.492) | 0.00 (0.000) |
| Insomnia or Problems Sleeping ** | |||||||
| Day 6 | −0.12 (0.697) | 0.13 (1.204) | 0.08 (0.534) | 0.13 (0.684) | 0.14 (1.142) | −0.40 (0.910) | 0.04 (1.050) |
| Day 7 | −0.04 (0.691) | −0.33 (0.961) | 0.39 (0.832) | −0.04 (0.749) | 0.22 (0.632) | −0.67 (0.961) | 0.18 (0.639) |
| Day 8 | 0.15 (0.427) | −0.07 (0.535) | 0.31 (1.078) | 0.30 (0.483) | −0.41 (0.779) | −0.45 (1.039) | 0.08 (1.017) |
| Day 9 | 0.28 (1.064) | −0.14 (0.802) | 0.20 (0.753) | −0.15 (0.580) | −0.38 (0.644) | −0.88 (0.991) | 0.31 (0.651) |
| Day 10 | 0.14 (0.244) | 0.00 (0.316) | 0.07 (0.189) | −0.30 (0.978) | −0.27 (0.564) | −0.58 (1.393) | 0.19 (0.594) |
| Day 11 | −0.14 (0.945) | −0.20 (0.570) | −0.36 (0.627) | −0.19 (0.594) | −0.41 (0.769) | −0.42 (0.861) | −0.29 (0.699) |
| Day 12 | −0.07 (0.189) | −0.70 (0.570) | −0.33 (0.876) | 0.25 (0.598) | 0.27 (1.272) | −0.83 (0.816) | −0.08 (0.665) |
| Clinical Opiate Withdrawal Scale (COWS) | |||||||
| Resting Pulse Rate | |||||||
| Day 6 | 0.15 (0.523) | −0.09 (1.255) | −0.08 (0.494) | −0.05 (0.329) | −0.26 (0.515) | −0.13 (0.550) | 0.32 (0.690) |
| Day 7 | 0.12 (0.650) | −0.21 (0.782) | 0.06 (0.539) | −0.08 (0.572) | −0.06 (0.704) | −0.13 (0.569) | −0.11 (0.881) |
| Day 8 | −0.31 (0.560) | 0.00 (0.408) | −0.13 (0.428) | −0.20 (0.537) | −0.19 (0.873) | 0.05 (0.725) | 0.35 (1.197) |
| Day 9 | 0.11 (0.858) | −0.21 (0.636) | 0.05 (0.550) | −0.10 (0.394) | 0.00 (0.522) | 0.19 (0.884) | 0.56 (0.982) |
| Day 10 | 0.00 (0.408) | −0.17 (1.033) | −0.14 (0.627) | 0.15 (0.337) | 0.05 (0.416) | 0.00 (0.447) | 0.19 (0.651) |
| Day 11 | 0.64 (0.556) | −0.30 (0.570) | −0.29 (1.113) | 0.13 (0.518) | −0.23 (0.410) | −0.08 (0.492) | −0.07 (0.787) |
| Day 12 | |||||||
| Restlessness | |||||||
| Day 6 | −0.03 (0.413) | 0.25 (0.658) | −0.13 (0.483) | −0.55 (0.705) | −0.31 (0.622) | −0.17 (0.900) | −0.02 (0.699) |
| Day 7 | 0.46 (0.776) | −0.08 (0.764) | −0.14 (0.703) | 0.04 (0.776) | −0.25 (0.658) | −0.42 (0.821) | −0.14 (0.886) |
| Day 8 | 0.08 (0.607) | −0.14 (0.244) | 0.03 (0.562) | −0.20 (0.675) | −0.78 (0.816) | −0.28 (0.618) | −0.27 (0.665) |
| Day 9 | 0.06 (0.391) | 0.14 (0.627) | −0.10 (0.394) | −0.15 (0.412) | −0.25 (0.866) | −0.94 (0.863) | −0.06 (0.464) |
| Day 10 | −0.14 (1.029) | −0.33 (0.408) | −0.07 (0.345) | −0.25 (0.264) | −0.25 (0.866) | −0.17 (0.606) | −0.19 (0.259) |
| Day 11 | 0.00 (0.289) | −1.00 (0.612) | −0.25 (0.418) | −0.13 (0.231) | −0.50 (0.500) | −0.25 (0.418) | 0.17 (0.516) |
| Day 12 | |||||||
| Pupil | |||||||
| Day 6 | −0.06 (0.243) | 0.00 (0.000) | −0.13 (0.222) | 0.00 (0.236) | 0.05 (0.269) | 0.20 (0.316) | 0.00 (0.144) |
| Day 7 | 0.04 (0.247) | −0.08 (0.289) | −0.08 (0.192) | −0.12 (0.300) | −0.13 (0.289) | 0.17 (0.326) | 0.04 (0.237) |
| Day 8 | 0.04 (0.139) | −0.14 (0.378) | 0.16 (0.507) | −0.10 (0.316) | −0.13 (0.289) | 0.00 (0.354) | −0.08 (0.277) |
| Day 9 | 0.06 (0.167) | 0.00 (0.000) | −0.05 (0.158) | −0.10 (0.316) | −0.08 (0.195) | −0.19 (0.458) | 0.22 (0.667) |
| Day 10 | −0.07 (0.189) | 0.00 (0.000) | −0.05 (0.158) | 0.00 (0.000) | −0.05 (0.151) | 0.00 (0.000) | −0.13 (0.354) |
| Day 11 | 0.00 (0.000) | 0.10 (0.224) | 0.00 (0.000) | 0.00 (0.000) | 0.00 (0.224) | 0.00 (0.316) | 0.00 (0.000) |
| Day 12 | 0.00 (0.000) | 0.00 (0.000) | 0.00 (0.000) | 0.00 (0.000) | −0.09 (0.202) | −0.17 (0.258) | 0.00 (0.000) |
| Bone and Joint Pain | |||||||
| Day 6 | −0.09 (0.404) | 0.00 (0.632) | −0.25 (0.473) | −0.08 (0.584) | 0.05 (0.650) | 0.03 (0.694) | −0.04 (0.455) |
| Day 7 | 0.12 (0.506) | 0.00 (0.603) | −0.22 (0.624) | −0.04 (0.431) | −0.09 (0.638) | −0.08 (0.417) | 0.04 (0.571) |
| Day 8 | 0.35 (0.427) | −0.07 (0.450) | −0.13 (0.645) | −0.15 (0.530) | −0.25 (0.483) | 0.00 (0.707) | −0.08 (0.760) |
| Day 9 | −0.33 (0.433) | −0.07 (0.535) | −0.20 (0.632) | −0.30 (0.350) | −0.08 (0.515) | −0.06 (0.320) | 0.44 (0.726) |
| Day 10 | 0.00 (0.500) | 0.17 (0.816) | 0.21 (0.488) | 0.00 (0.236) | −0.09 (0.491) | −0.33 (0.516) | 0.06 (0.320) |
| Day 11 | −0.07 (0.345) | 0.10 (0.418) | 0.07 (0.189) | −0.13 (0.354) | 0.00 (0.447) | −0.33 (0.408) | 0.00 (0.500) |
| Day 12 | 0.00 (0.408) | 0.00 (0.354) | −0.33 (0.408) | 0.13 (0.231) | −0.36 (0.452 | −0.25 (0.274) | 0.08 (0.204) |
| Runny Nose | |||||||
| Day 6 | 0.00 (0.433) | −0.19 (0.574) | −0.13 (0.222) | −0.29 (0.481) | 0.00 (0.316) | 0.03 (0.516) | 0.08 (0.493) |
| Day 7 | 0.12 (0.546) | −0.17 (0.807) | 0.03 (0.675) | −0.42 (0.400) | −0.03 (0.562) | 0.04 (0.542) | 0.21 (0.642) |
| Day 8 | 0.19 (0.693) | −0.07 (0.189) | −0.03 (0.464) | −0.05 (0.550) | −0.16 (0.769) | 0.06 (0.527) | 0.31 (0.778) |
| Day 9 | −0.11 (0.546) | −0.36 (0.627) | −0.25 (0.717) | −0.05 (0.284) | −0.25 (0.544) | −0.38 (0.518) | 0.11 (0.220) |
| Day 10 | 0.00 (0.000) | −0.50 (0.548) | −0.21 (0.393) | −0.05 (0.438) | −0.23 (0.261) | −0.17 (0.408) | 0.00 (0.535) |
| Day 11 | −0.14 (0.476) | −0.10 (0.224) | −0.14 (0.378) | 0.19 (0.530) | 0.00 (0.548) | −0.25 (0.418) | −0.07 (0.189) |
| Day 12 | −0.29 (0.488) | 0.00 (0.000) | −0.08 (0.492) | −0.13 (0.231) | 0.00 (0.447) | 0.00 (0.000) | 0.00 (0.000) |
| Gastrointestinal Upset | |||||||
| Day 6 | 0.24 (0.903) | 0.06 (0.772) | −0.20 (0.523) | −0.24 (0.695) | −0.36 (0.615) | −0.07 (0.372) | 0.04 (0.519) |
| Day 7 | −0.12 (0.740) | 0.00 (0.879) | −0.17 (0.728) | −0.08 (0.760) | −0.44 (0.964) | 0.29 (1.373) | −0.11 (0.738) |
| Day 8 | 0.35 (1.125) | −0.21 (0.488) | −0.13 (0.866) | −0.10 (0.810) | −0.47 (0.670) | −0.50 (0.866) | 0.19 (0.663) |
| Day 9 | 0.28 (1.034) | −0.86 (0.988) | 0.35 (1.634) | −0.10 (0.394) | −0.08 (0.557) | −0.25 (0.655) | 0.33 (1.199) |
| Day 10 | −0.29 (0.488) | −0.08 (0.736) | 0.07 (0.345) | −0.30 (0.587) | −0.23 (0.564) | −0.50 (0.632) | −0.13 (0.991) |
| Day 11 | −0.07 (0.189) | −0.30 (0.274) | −0.36 (0.476) | 0.06 (0.320) | 0.00 (0.447) | −0.33 (0.683) | −0.07 (0.345) |
| Day 12 | −0.14 (0.244) | −0.10 (0.224) | −0.42 (0.801) | −0.19 (0.594) | 0.09 (1.114) | −0.50 (0.447) | 0.17 (0.516) |
| Tremor | |||||||
| Day 6 | −0.18 (0.431) | −0.03 (0.427) | −0.10 (0.348) | −0.08 (0.301) | −0.14 (0.392) | 0.07 (0.530) | 0.00 (0.323) |
| Day 7 | −0.08 (0.400) | −0.50 (0.477) | −0.19 (0.349) | −0.12 (0.219) | −0.25 (0.408) | −0.04 (0.450) | 0.00 (0.196) |
| Day 8 | 0.23 (0.725) | −0.07 (0.535) | −0.19 (0.443) | −0.15 (0.337) | −0.19 (0.602 | −0.50 (0.433) | −0.04 (0.139) |
| Day 9 | 0.00 (0.433) | −0.07 (0.450) | −0.10 (0.316) | 0.00 (0.236) | −0.33 (0.389) | −0.50 (0.655) | 0.06 (0.167) |
| Day 10 | 0.14 (0.378) | −0.08 (0.376) | 0.07 (0.450) | −0.05 (0.158) | −0.14 (0.234) | −0.17 (0.258) | 0.06 (0.177) |
| Day 11 | 0.00 (0.000) | −0.10 (0.224) | −0.07 (0.189) | 0.13 (0.354) | −0.18 (0.337) | −0.33 (0.408) | 0.00 (0.289) |
| Day 12 | 0.07 (0.189) | 0.00 (0.000) | 0.00 (0.000) | 0.00 (0.000) | −0.09 (0.302) | −0.25 (0.418) | 0.00 (0.000) |
| Yawning | |||||||
| Day 6 | 0.03 (0.121 | 0.06 (0.310) | 0.00 (0.162) | −0.11 (0.488) | −0.02 (0.109) | 0.13 (0.352) | 0.10 (0.323) |
| Day 7 | 0.08 (0.344) | −0.08 (0.359) | −0.06 (0.162) | 0.08 (0.188) | −0.09 (0.272) | −0.08 (0.515) | 0.04 (0.365) |
| Day 8 | 0.23 (0.330) | −0.14 (0.244) | 0.00 (0.365) | 0.10 (0.316) | −0.16 (0.397) | 0.06 (0.464) | −0.04 (0.380) |
| Day 9 | −0.22 (0.363) | 0.00 (0.500) | 0.10 (0.316) | −0.10 (0.211) | −0.17 (0.537) | −0.25 (0.535) | 0.00 (0.250) |
| Day 10 | 0.00 (0.000) | 0.00 (0.000) | 0.07 (0.189) | 0.00 (0.236) | 0.00 (0.224) | 0.00 (0.000) | 0.00 (0.267) |
| Day 11 | 0.07 (0.189) | 0.20 (0.758) | −0.07 (0.189) | −0.06 (0.177) | 0.00 (0.224) | 0.00 (0.447) | −0.14 (0.244) |
| Day 12 | 0.07 (0.189) | 0.10 (0.224) | −0.25 (0.418) | −0.06 (0.177) | 0.00 (0.000) | −0.33 (0.408) | −0.08 (0.204) |
| Anxiety | |||||||
| Day 6 | −0.03 (0.739) | −0.06 (0.629) | −0.18 (0.520) | −0.05 (0.575) | −0.29 (0.734) | 0.00 (0.535) | −0.20 (0.722) |
| Day 7 | 0.12 (0.583) | −0.04 (0.940) | 0.06 (0.539) | 0.12 (0.618) | 0.06 (0.443) | −0.38 (0.711) | 0.07 (0.385) |
| Day 8 | −0.23 (0.599) | −0.29 (0.567) | 0.00 (0.483) | −0.05 (0.438) | −0.13 (0.387) | −0.33 (0.612) | 0.19 (0.435) |
| Day 9 | 0.28 (1.064) | 0.14 (0.900) | −0.45 (0.643) | −0.10 (0.394) | 0.00 (0.369) | −0.38 (0.443) | 0.11 (0.333) |
| Day 10 | −0.07 (0.673) | 0.00 (0.632) | −0.07 (0.450) | −0.20 (0.483 | −0.09 (0.625) | −0.17 (0.516) | −0.06 (0.320) |
| Day 11 | −0.07 (0.345) | 0.00 (0.612) | −0.14 (0.244) | 0.00 (0.267) | 0.14 (0.452) | −0.17 (0.683) | 0.07 (0.189) |
| Day 12 | 0.07 (0.189) | −0.40 (0.962) | −0.25 (0.418) | −0.06 (0.320) | −0.14 (0.505) | −0.33 (0.606) | 0.25 (0.418) |
| Gooseflesh | |||||||
| Day 6 | −0.09 (0.364) | 0.00 (0.548) | −0.23 (0.550) | −0.08 (0.607) | −0.14 (0.655) | 0.10 (0.687) | −0.12 (0.415) |
| Day 7 | 0.46 (0.721) | −0.46 (1.076) | −0.08 (0.354) | −0.23 (1.033 | −0.47 (0.903) | 0.00 (0.000) | −0.11 (0.401) |
| Day 8 | 0.58 (0.976) | −0.43 (0.732) | 0.19 (0.750) | 0.15 (0.474) | −0.19 (1.078) | −0.33 (0.661) | 0.11 (0.924) |
| Day 9 | −0.83 (1.090) | −0.21 (0.567) | 0.00 (0.000) | 0.15 (0.474) | −0.08 (1.258) | −0.38 (1.061) | 0.33 (1.000) |
| Day 10 | −0.21 (0.567) | 0.00 (0.000) | 0.00 (0.000) | 0.00 (0.000) | −0.55 (1.011) | −0.50 (0.775) | 0.00 (0.000) |
| Day 11 | 0.00 (0.866) | 0.00 (0.000) | 0.00 (0.000) | 0.00 (0.000) | −0.27 (0.905) | 0.00 (0.000) | 0.00 (0.000) |
| Day 12 | 0.00 (0.000) | −0.30 (0.671) | 0.00 (0.000) | 0.00 (0.000) | −0.55 (1.011) | 0.00 (0.000) | 0.00 (0.000) |
| Agitation and Calmness Scale (ACES) Total Score | |||||||
| Post First Dose | |||||||
| Day 6 | 4.6 (1.27) | 3.4 (1.71) | 4.4 (1.35) | 4.9 (1.31) | 4.7 (1.35) | 4.9 (1.73) | 4.3 (1.40) |
| Day 7 | 4.3 (0.95) | 3.6 (1.83) | 3.8 (1.29) | 3.9 (0.76) | 4.1 (1.48) | 4.4 (1.73) | 4.1 (0.86) |
| Day 8 | 3.8 (1.17) | 4.1 (1.07) | 4.0 (1.26) | 4.6 (1.43) | 4.2 (1.17) | 5.0 (1.83) | 4.1 (0.83) |
| Day 9 | 3.0 (0.87) | 4.1 (1.46) | 3.7 (0.67) | 4.5 (1.18) | 3.5 (0.80) | 4.7 (2.06) | 3.8 (0.46) |
| Day 10 | 4.1 (1.77) | 3.8 (0.98) | 4.1 (0.38) | 4.3 (1.06) | 4.3 (1.01) | 4.3 (1.37) | 4.4 (0.92) |
| Day 11 | 4.7 (1.50) | 4.0 (0.71) | 4.1 (0.38) | 4.1 (0.64) | 3.9 (0.94) | 4.2 (0.41) | 4.6 (1.13) |
| Day 12 | 4.3 (0.76) | 4.4 (1.14) | 4.7 (1.21) | 4.0 (0.00) | 4.1 (0.83) | 4.8 (1.33) | 4.0 (1.10) |
| Post Second Dose | |||||||
| Day 6 | 3.9 (0.73) | 3.5 (0.78) | 3.7 (0.75) | 3.6 (0.61) | 4.1 (1.00) | 3.6 (0.77) | 3.8 (0.73) |
| Day 7 | 3.8 (0.38) | 3.2 (0.75) | 3.7 (0.70) | 3.9 (1.04) | 3.8 (0.41) | 3.5 (0.71) | 4.1 (0.27) |
| Day 8 | 3.8 (0.67) | 3.9 (0.38) | 3.7 (0.63) | 3.6 (0.70) | 4.0 (0.43) | 3.9 (0.35) | 3.7 (0.90) |
| Day 9 | 4.3 (0.49) | 4.0 (0.58) | 4.1 (0.38) | 3.8 (0.42) | 3.8 (0.60) | 4.4 (1.06) | 3.9 (0.83 |
| Day 10 | 4.0 (0.00) | 3.6 (0.89) | 4.0 (0.00) | 3.7 (0.48) | 3.9 (0.54) | 4.2 (0.41) | 3.9 (0.35) |
| Day 11 | 4.0 (0.00) | 3.2 (1.30) | 4.0 (0.00) | 3.8 (0.46) | 3.7 (0.47) | 4.3 (1.37) | 3.8 (0.41) |
| Day 12 | 3.9 (0.69) | 4.0 (0.00) | 4.2 (0.41) | 4.0 (0.00) | 3.9 (0.33) | 3.7 (0.82) | 3.6 (0.89) |
*
Average change refers to the average of the two change scores at 2-hour post-dose from the respective pre-dose scores. Bolded numbers indicate a statistically significant difference from placebo (p<.05).
**
Assessment of insomnia referred to the previous night.