Table 1. Participant demographic and clinical characteristics.
| Part A: Healthy Volunteers | Part B: Opioid-tolerant Patients | |||||
|---|---|---|---|---|---|---|
| Buprenorphine concentration | 0.2 ng/mL | 0.5 ng/mL | 1 ng/mL | 2 ng/mL | 5 ng/mL | Grouped |
| (n = 8) | (n = 6) | (n = 2) | (n = 3) | (n = 3) | (n = 8) | |
| Sex, N (%) | ||||||
| Male | 4 (50) | 3 (50) | 1 (50) | 1 (33) | 1 (33) | 3 (38) |
| Female | 4 (50) | 3 (50) | 1 (50) | 2 (67) | 2 (67) | 5 (63) |
| Age, mean (SD) or range, y | 23.8 ± 4.6 | 24.5 ± 2.4 | 44–46 | 31–43 | 34–52 | 42 ± 8 |
| Ethnicity, N (%) | ||||||
| White | 8 (100) | 5 (83) | 2 (100) | 3 (100) | 3 (100) | 8 (100) |
| Native Hawaiian | 1 (17) | |||||
| Weight, mean (SD) or range, kg | 74.2 ± 6.9 | 67.9 ± 6.6 | 70–93 | 70–87 | 65–89 | 78 ± 10 |
| BMI, mean (SD) or range, kg/m2 | 23.5 ± 2.2 | 22.4 ± 1.6 | 23.6–29.6 | 22.0–30.8 | 21.0–31.5 | 25.9 ± 4.2 |
| Daily MME, mean (SD) or range, mg | NA | NA | 90–150 | 90–480 | 90–270 | 203 ± 135 |
| Drug Usage per Participanta | NA | NA | • Oxycodone 60 mg/d | • Fentanyl patch 75 mcg/h; oxycodone 90 mg/d; tapentadol 50 mg/d | • Heroin 250 mg/d (smoke); cocaine; marijuana | |
| • Fentanyl patch 25 mcg/h; oxycodone 60 mg/d; marijuana | • Buprenorphine 16 mg/d; cocaine; marijuana | • Fentanyl patch 50 mcg/h | ||||
| • Oxycodone 60 mg/d; marijuana | • Fentanyl patch 75 mcg/h; oxycodone 60 mg/d; marijuana | |||||
BMI, body mass index; MME, Morphine Milligram Equivalents; N, sample size; NA, not applicable; SD: standard deviation.
aTailored substitution schedules with oxycodone began a minimum of 48 hours before the first experiment to ensure washout of each patient’s usual opioids at baseline.