Table 1.
Baseline participant characteristics
| NTX/BUP (n = 50) | PBO‐N/BUP (n = 51) | Total (N = 101) a | |
|---|---|---|---|
| Age, median (range), y | 35.0 (20‐57) | 33.0 (23‐57) | 34.0 (20‐57) |
| Male sex, n (%) | 36 (72) | 35 (69) | 71 (70.3) |
| Race, n (%) | |||
| White | 46 (92) | 47 (92) | 93 (92.1) |
| Black or African‐American | 4 (8) | 3 (6) | 7 (6.9) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 2 (4) | 3 (6) | 5 (5.0) |
| BMI, median (range), kg/m2 | 25.7 (18.8‐38.5) | 25.3 (18.6‐39.2) | 25.5 (18.6‐39.2) |
| COWS score, median (range) | 3.0 (0‐15) | 2.5 (0‐11) | 3.0 (0‐15) |
| SOWS score, median (range) | 2.0 (0‐39) | 2.0 (0‐47) | 2.0 (0‐47) |
| VAS craving score, median (range) | 1.0 (0‐100) | 1.0 (0‐80) | 1.0 (0‐100) |
| HAM‐D score, median (range) | 3.0 (0‐11) | 2.0 (0‐24) | 3.0 (0‐24) |
| Duration of OUD, n (%) | |||
| >6 months but <12 months | 5 (10.0) | 9 (17.7) | 14 (13.9) |
| 1‐2 years | 8 (16.0) | 5 (9.8) | 13 (12.9) |
| 2‐3 years | 6 (12.0) | 5 (9.8) | 11 (10.9) |
| 3‐5 years | 11 (22.0) | 9 (17.7) | 20 (19.8) |
| >5 years | 20 (40.0) | 23 (45.1) | 43 (42.6) |
| BUP dose, n (%) | |||
| 8 mg/d | 30 (60) | 31 (61) | 61 (60.4) |
| <8 mg/d | 20 (40) | 20 (39) | 40 (39.6) |
| Duration of current BUP treatment, n (%) | |||
| >3 months but <6 months | 6 (12) | 6 (12) | 12 (11.9) |
| 6‐12 months | 9 (18) | 9 (18) | 18 (17.8) |
| 1‐2 years | 13 (26) | 17 (33) | 30 (29.7) |
| 2‐3 years | 8 (16) | 8 (16) | 16 (15.8) |
| >3 years | 14 (28) | 11 (22) | 25 (24.8) |
BMI = body mass index; BUP = buprenorphine; COWS = Clinical Opiate Withdrawal Scale; HAM‐D = Hamilton Depression Rating Scale; NTX = oral naltrexone; OUD = opioid use disorder; PBO‐N = placebo for oral naltrexone; SOWS = Subjective Opiate Withdrawal Scale; VAS = visual analog scale.
a
One participant was assigned to the NTX/BUP group, but he/she received PBO‐N/BUP.