Table 2.
Day 8 |
Day 15 |
|||||
---|---|---|---|---|---|---|
Placeboa (daily) | 40 mgb (daily) | Placebob (daily) | 90 mgb (day 15 only) | 40 mgb (daily) | ||
Heart rate increase (bpm) | Mean | 47.8c | 12.2 | 38.4 | 13.7 | 13.2 |
Median | 49.4 | 10.6 | 37.4 | 11.8 | 14.4 | |
Range | 15.4−95.2 | 2−19.8 | 18−74.2 | −1.6−33.2 | 0.4−31.2 | |
95% CI | 37.7−57.9 | 9.1−15.3 | 29.1−47.8 | 6.8−20.6 | 7.9−18.6 | |
Tmax (min) | Mean change | 16.3c | 22.5 | 16.2 | 26.4 | 22.4 |
Median | 9.0 | 14.0 | 7.3 | 34.0 | 34.0 | |
Range | 2−54 | 3−65 | 4−35 | 1−67 | 1−35 | |
95% CI | 10.6−21.7 | 11.2−33.7 | 7.6−24.8 | 14.5−38.2 | 13.2−31.6 | |
AUC0−55 min | Mean Change | 31.6c | 2.8 | 25.3 | 4.4 | 4.1 |
Median | 29.4 | 2.5 | 22.5 | 3.4 | 2.5 | |
Range | 6.3−74.2 | −2.6−10.9 | 7.5−52.3 | −7.5−16.7 | −4.1−13.5 | |
95% CI | 23.6−39.7 | 0.6−5.1 | 17.7−32.9 | −.0.4−9.3 | 0.5−7.7 | |
VAS (mm) composite | Mean Peak | 80.0 | 64.6 | 69.8 | 49.3 | 59.8 |
Median | 79.0 | 64.7 | 76.7 | 76.7 | 65.3 | |
Range | 48−100 | 31.3−98 | 4.7−100 | 3.3−84.7 | 4.7−96.7 | |
95% CI | 72.9−87.0 | 54.1−75.1 | 51.1−88.4 | 27.7−70.9 | 43.9−75.8 | |
Tmax (min) | Mean | 18.1 | 25.3 | 19.7 | 17.5 | 14.0 |
Median | 13.5 | 23.7 | 24 | 17 | 12 | |
Range | 7−60 | 7−59 | 6−30.2 | 6−28 | 7−23 | |
95% CI | 12.9−23.2 | 17.4−33.1 | 13.5−25.9 | 13.4−21.7 | 10.2−17.9 | |
AUC0−55 min | Mean | 66.3 | 53.2 | 60.3 | 40.7 | 38.1 |
Median | 66.5 | 48.2 | 53.2 | 61.4 | 41.8 | |
Range | 28−99.9 | 13.7−96.5 | 2.9−97.8 | 0.6−79.2 | 0.6−88.4 | |
95% CI | 56.2−76.3 | 40.5−66.0 | 41.0−79.6 | 20.1−61.3 | 22.6−53.5 | |
M-scale | Mean Peak | 8.1 | 5.5 | 6.5 | 5.0 | 5.0 |
Median | 8.5 | 6 | 6 | 5 | 4 | |
Range | 2−12 | 2−11 | 1−12 | 0−12 | 0−11 | |
95% CI | 6.8−9.4 | 4.0−7.1 | 4.2−8.9 | 2.7−7.3 | 2.6−7.4 | |
Tmax (min) | Mean | 23.8 | 19.9 | 19.3 | 13.9 | 14.5 |
Median | 22.0 | 10 | 22 | 8 | 12 | |
Range | 8−65 | 8−62 | 7−31 | 7−28 | 7−28 | |
95% CI | 16.5−31.2 | 7.6−32.3 | 14.1−24.5 | 9.4−18.4 | 9.8−19.2 | |
AUC0−55 min | Mean | 6.1 | 3.6 | 5.5 | 3.7 | 3.7 |
Median | 6.5 | 4.3 | 3.9 | 3.0 | 1.7 | |
Range | 1.1−10.7 | 0.3−7.6 | 0.2−11.9 | 0−11.8 | 0−10.2 | |
95% CI | 4.8−7.5 | 2.3−5.0 | 3.1−7.9 | 1.5−5.9 | 1.3−6.1 |
Heart rate Change from baseline (before oral rimonabant dosing); VAS composite mean of scores on three 100-mm visual analog scales for “How high do you feel now?”, “How strong is the drug effect you feel now?” and “How stoned on marijuana are you now?” Maximum possible score=100; M-scale marijuana subscale of Addiction Research Center Inventory. Maximum possible score=12; Tmax time during session that maximum value of variable was reached
n=22
n=11
n=23