Table 5.
UDS, Self-Reported Opioid Use and Craving of Randomized Participants by Treatment Arm
| PLB | BUP 4 | p-value PLB vs BUP4 | BUP 16 | p-value PLB vs BUP16 | |
|---|---|---|---|---|---|
| % Opioid-Negative UDS | |||||
| Baseline* | 100% | 100% | 100% | ||
| Evaluation Period | 99.5% | 99.0% | 0.161 | 98.2% | 0.110 |
| 1-Month Follow-up | 95.9% | 98.9% | 0.198 | 93.5% | 0.473 |
| 3-Month Follow-up | 95.7% | 95.4% | 0.910 | 95.4% | 0.936 |
| Mean Days of Self-Reported Opioid Use in Past 30 (SD)** | |||||
| Baseline | 2.0 (4.2) | 1.7 (3.9) | 0.295 | 2.2 (3.9) | 0.295 |
| Evaluation Period | 0.45 (3.09) | 0.09 (0.32) | 0.141 | 0.18 (0.92) | 0.826 |
| 1-Month Follow-up | 0.26 (1.59) | 0.19 (1.02) | 0.380 | 0.97 (3.81) | 0.046 |
| 3-Month Follow-up | 0.61 (3.08) | 0.59 (3.49) | 0.488 | 0.82 (3.81) | 0.339 |
| Mean VAS Opioid Craving Score (SD)*** | |||||
| Baseline | 22.2 (23.9) | 23.6 (22.9) | 0.334 | 25.4 (28.1) | 0.192 |
| Evaluation Period | 6.8 (14.1) | 7.3 (16.9) | 0.331 | 8.1 (17.8) | 0.161 |
| 1-Month Follow-up | 6.3 (14.1) | 5.5 (13.7) | 0.338 | 11.3 (21.9) | 0.032 |
| 3-Month Follow-up | 3.5 (8.1) | 7.9 (17.2) | 0.014 | 10.7 (20.7) | 0.001 |
*
Study design required an opioid-negative UDS at baseline to proceed to randomization
**
Significant reductions (p<0.001) in self-reported opioid use in past 30 days (ASI) from baseline to Week 8, baseline to 1-Month follow-up, and baseline to 3-Month follow-up for all treatment conditions.
***
Significant reductions (p<0.001) in opioid craving from baseline to all time points for all treatment conditions.