Table 2 Summary of primary outcomes.
Primary outcomes | Placebo | Hydromorphone 4 mg, oral | Dronabinol 10 mg, oral | Hydromorphone 4 mg, oral + Dronabinol 10 mg, oral | P value (partial eta2) | ||||
|---|---|---|---|---|---|---|---|---|---|
Mean/% | SEM | Mean/% | SEM | Mean/% | SEM | Mean/% | SEM | ||
Quantitative sensory testing | |||||||||
Acute pain model | |||||||||
Pressure pain threshold (0–1200 kPa) | 446.27a | 27.10 | 535.32a | 30.52 | 488.05 | 34.05 | 492.18 | 34.16 | 0.018 (0.048) |
Heat pain threshold (°C) | 44.63 | 0.48 | 45.24 | 0.37 | 44.85 | 0.50 | 45.13 | 0.49 | 0.216 (0.010) |
Heat pain tolerance (°C) | 48.06 | 0.27 | 48.15 | 0.23 | 48.02 | 0.24 | 48.27 | 0.27 | 0.453 (−0.002) |
Mechanical temporal summation | 3.90 | 0.63 | 3.44 | 0.55 | 5.23 | 1.17 | 5.10 | 1.58 | 0.322 (0.004) |
Thermal temporal summation | 0.59 | 0.09 | 0.66 | 0.10 | 0.84 | 0.23 | 0.75 | 0.11 | 0.503 (0.004) |
Cold pressor threshold (time in s) | 16.19a | 1.65 | 19.66b | 2.14 | 15.16b,c | 1.52 | 19.97a,c | 2.16 | 0.001 (0.085) |
Cold pressor threshold severity rating (0–100 VAS) | 59.44 | 5.75 | 57.98 | 5.15 | 64.91 | 4.93 | 60.54 | 5.06 | 0.153 (0.017) |
Cold pressor tolerance (time in s) | 53.99a | 9.08 | 69.27 | 10.15 | 51.84b | 9.32 | 72.04a,b | 12.51 | 0.002 (0.080) |
Conditioned pain modulation, mechanical temporal summation | −9.89 | 2.91 | 10.73 | 2.99 | −14.41 | 3.63 | −15.43 | 3.33 | 0.437 (−0.002) |
Conditioned pain modulation, pressure pain threshold | 100.51 | 15.94 | 120.14 | 15.39 | 109.30 | 15.10 | 98.84 | 8.96 | 0.781 (−0.013) |
Chronic pain model | |||||||||
Capsaicin, thermal threshold | 39.55 | 0.47 | 39.36 | 0.46 | 38.84a | 0.39 | 40.25a | 0.44 | 0.001 (0.058) |
Capsaicin, mechanical temporal summation | 1.83 | 0.31 | 1.51 | 0.10 | 1.66 | 0.22 | 1.75 | 0.18 | 0.700 (−0.011) |
Global QST measures | |||||||||
Central sensitization (z-score) | −0.14a | 0.06 | −0.32a,b | 0.05 | −0.19b | 0.06 | −0.23 | 0.05 | 0.004 (0.072) |
General pain sensitivity (z-score) | −0.04a,b | 0.10 | −0.30a,c | 0.10 | −0.09c,d | 0.10 | −0.27b,d | 0.12 | <0.001 (0.102) |
Clinical pain severity (0–100 VAS) | 12.57 | 2.92 | 9.32 | 2.71 | 13.46 | 2.93 | 10.95 | 2.74 | 0.302 (0.005) |
Physical functioning tests | |||||||||
2-min walking distance | 289.46 | 11.41 | 295.97 | 12.62 | 283.09 | 11.22 | 285.84 | 13.95 | 0.058 (0.031) |
Tug time | 11.90 | 0.67 | 12.20 | 0.71 | 12.00 | 0.71 | 11.91 | 0.62 | 0.620 (−0.008) |
Stair time | 6.18 | 0.52 | 6.13 | 0.48 | 5.98 | 0.49 | 6.04 | 0.43 | 0.861 (−0.015) |
Participant ratings (0–100 VAS) | |||||||||
Drug Effect | 16.35a,b | 3.70 | 26.06c,d | 4.61 | 52.92a,c | 5.80 | 57.57b,d | 5.32 | <0.001 (0.338) |
Good Effect | 23.38a | 4.94 | 40.60a | 5.85 | 39.59 | 5.67 | 34.70 | 5.14 | 0.018 (0.048) |
Bad Effect | 5.92a,b | 2.16 | 7.54c,d | 2.48 | 33.16a,c | 5.82 | 38.35b,d | 6.26 | <0.001 (0.270) |
High | 7.03a,b | 2.52 | 15.03c,d | 4.01 | 40.62a,c | 5.93 | 37.24b,d | 5.19 | <0.001 (0.264) |
Like the Way I Feel | 49.59 | 5.37 | 59.86 | 5.01 | 52.03 | 5.47 | 45.14 | 5.73 | 0.137 (0.018) |
Nausea | 1.54a | 0.65 | 7.14 | 3.13 | 7.32 | 2.92 | 15.65a | 4.21 | 0.012 (0.055) |
Human abuse potential (HAP) measures | |||||||||
Enjoyed medication (% Yes) | 21.2a,b | 35.5 | 40.6a | 38.5b | 0.11 | 0.001 (0.328) | |||
Would take medication again (0–5) | 0.79 | 0.19 | 1.39 | 0.24 | 1.09 | 0.26 | 1.19 | 0.29 | 0.185 (0.013) |
≥60 on “High” rating scale (%) | 0%a,b | 11.8%c,d | 47.1%a,c | 47.1%b,d | 0.002 (0.389) | ||||
Willingness to pay for medication ($) | 17.34 | 9.74 | 16.29 | 7.34 | 18.50 | 8.83 | 24.31 | 13.49 | 0.827 (-0.014) |
Cognitive testing | |||||||||
Circular lights (max per minutes) | 33.11a | 1.55 | 29.50a | 1.54 | 32.33 | 1.85 | 32.16 | 1.60 | 0.029 (0.042) |
DSST (proportion correct) | 0.60 | 0.06 | 0.58 | 0.07 | 0.68 | 0.05 | 0.64 | 0.07 | 0.491 (-0.004) |
PASAT, mean reaction time correct (sec) | 1694.87 | 38.00 | 1748.40 | 63.84 | 1731.30 | 29.72 | 1788.52 | 34.80 | 0.343 (0.003) |
PASAT, correct (%) | 43.67a | 4.07 | 34.98a | 4.30 | 40.57 | 3.78 | 42.19 | 4.05 | 0.023 (0.045) |