Table 2 Summary of primary outcomes.

From: Within-subject, double-blind, randomized, placebo-controlled evaluation of combining the cannabinoid dronabinol and the opioid hydromorphone in adults with chronic pain

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)

  1. Outcomes represent mean peak ratings or percent participants for each condition (N = 37). Matching superscripts indicate significant (p < 0.05) differences in post-hoc comparisons. Partial eta2 effect sizes provided for significant results: small (0.01), medium (0.06), large (0.14).
  2. SEM standard error of the mean, DSST Digit Symbol Substitution Task, PASAT Paced Auditory Serial Addiction Task, VAS Visual Analog Scale.
  3. Statistically significant p-values are in bold.