Table 1.
Baseline characteristics of the full analysis set.
| Characteristic | SoC (n = 156) | BUP-XR (n = 158) | Overall (n = 314) |
|---|---|---|---|
| Clinic—participantsa | |||
| London | 46 (29.5) | 47 (29.8) | 93 (29.6) |
| Manchester | 9 (5.8) | 11 (7.0) | 20 (6.4%) |
| Newcastle | 51 (32.7) | 52 (32.9) | 103 (32.8) |
| West Midlands | 24 (15.4) | 23 (14.6) | 47 (15.0) |
| Tayside | 26 (16.7) | 25 (15.8) | 51 (16.2) |
| Participant—demographic characteristics | |||
| Age—years | 41.6 (8.2) | 42.5 (7.9) | 42.0 (8.1) |
| Sex—at birth | |||
| Male | 111 (71.2) | 122 (77.2) | 233 (74.2) |
| Female | 45 (28.9) | 36 (22.8) | 81 (25.8) |
| Ethnicity | |||
| White | 127 (81.4) | 136 (86.1) | 263 (83.8) |
| Black | 13 (8.3) | 12 (7.6) | 25 (7.9) |
| Mixed | 10 (6.4) | 7 (4.4) | 17 (5.4) |
| Asian | 4 (2.6) | 1 (0.6) | 5 (1.6) |
| Other | 2 (1.3) | 2 (1.3) | 4 (1.3) |
| Participant—clinical characteristics | |||
| Age (years) first received SoC (a) | 29.8 (9.3) | 30.4 (8.8) | 30.1 (9.0) |
| Duration of current SoC episode—mean weeks | 39.8 (2.4–167.3) | 58.9 (4.0–183.3) | 49.9 (3.0–176.6) |
| New admission for SoC | 44 (28.2) | 39 (24.6) | 83 (26.4) |
| OUD medication at start of screening (b) | |||
| BUP and BUP-NLX | 90 (57.7) | 82 (51.9) | 172 (54.8) |
| Dose—mg (mean [SD]; range) | 13.5 [5.3]; 4–26b | 12.7 [5.3]; 2–24 | 13.1 [5.3]; 2–26 |
| Espranor® | 3 (1.9) | 9 (5.7) | 12 (3.8) |
| Dose—mg (mean [SD]; range) | 15.3 [3.1]; 12–18 | 15.8 [2.9]; 10–18 | 15.7 [2.8]; 10–18 |
| MET | 15.0 (9.6) | 22 (13.9) | 37 (11.8) |
| Dose—mg (mean [SD]; range) | 29.5 [9.3]; 20–50 | 22.2 [7.7]; 4–30 | 25.2 [9.0]; 4–50 |
| Clinical assessments | |||
| OUD—drug type | |||
| Heroin | 142 (91.0) | 143 (90.5) | 285 (90.8) |
| Illicit/non-medical pharmaceutical opioid | 14 (9.0) | 15 (9.5) | 29 (9.2) |
| DSM-5 OUD status | |||
| Moderate | 5 (3.2) | 1 (0.6) | 6 (1.9) |
| Severe | 151 (96.8) | 157 (99.4) | 308 (98.1) |
| DSM-5 CUD status (c) | |||
| Missing | 17 (10.9) | 23 (14.6) | 40 (12.7) |
| No symptoms | 30 (19.2) | 29 (18.4) | 59 (18.8) |
| One symptom | 4 (2.6) | 9 (5.7) | 13 (4.1) |
| Mild | 9 (5.8) | 10 (6.3) | 19 (6.1) |
| Moderate | 14 (9.0) | 13 (8.2) | 27 (8.6) |
| Severe | 82 (52.6) | 74 (46.8) | 156 (49.7) |
| Drug use—past 28 days | |||
| Injectinga | 17 (10.9%) | 12 (7.6%) | 29 (9.2%) |
| Opioids | 74 (47.4%) | 64 (40.5%) | 138 (44.0%) |
| Cocaine | 80 (51.3%) | 73 (46.2%) | 153 (48.7%) |
| Benzodiazepines | 38 (24.4%) | 34 (21.5%) | 72 (22.9%) |
| Characteristic | SoC (n = 156) | BUP-XR (n = 158) | Overall (n = 314) |
|---|---|---|---|
| Clinical assessments–continued | |||
| Alcohol use—past 28 days (a) | |||
| Use of alcohol—participants | 89 (57.1) | 86 (54.4) | 175 (55.7) |
| Number of drinking days—meanc | 5.3 (8.6) | 5.1 (8.7) | 5.2 (8.6) |
| Drinks per drinking day—meanc | 9.3 (8.9) | 8.5 (8.3) | 8.9 (8.6) |
| Maximum drinks on drinking day—meanc | 14.3 (14.0) | 13.4 (14.0) | 13.9 (14.0) |
| Craving for opioids (a) | |||
| CEQ-F | 29.9 (34.3) | 27.8 (33.1) | 28.8 (33.8) |
| VAS-N | 27.4 (39.4) | 25.8 (38.4) | 26.6 (38.8) |
| VAS-W | 33.5 (38.9) | 31.0 (36.3) | 32.2 (37.6) |
| Craving for cocaine (c) | |||
| CEQ-F | 26.8 (34.9) | 26.5 (34.2) | 26.6 (34.5) |
| VAS-N | 18.6 (32.9) | 15.3 (29.3) | 16.9 (31.1) |
| VAS-W | 29.0 (37.6) | 27.6 (35.7) | 28.3 (36.6) |
| DERS—mean (d) | 44.8 (15.3) | 44.4 (15.2) | 44.6 (15.2) |
| QUIDS-SR—mean (a) | 8.5 (4.9) | 8.5 (4.8) | 8.5 (4.8) |
| WSAS—mean (d) | 17.0 (12.8) | 16.1 (13.6) | 16.5 (13.2) |
| Clinician-reported outcomes | |||
| ADAPT | |||
| OUD addiction severity—mean | 2.1 (1.7) | 1.9 (1.6) | 2.0 (1.7) |
| Concurrent problem complexity—mean | 3.1 (2.4) | 3.1 (2.7) | 3.1 (2.5) |
| Recovery strengths—mean | 7.0 (2.1) | 7.1 (2.2) | 7.0 (2.1) |
| GSI-S—severity of opioid-related problems | |||
| Extremely mild–mild | 90 (57.7) | 90 (57.0) | 180 (57.3) |
| Moderate–extreme | 66 (42.3) | 68 (43.0) | 134 (42.7) |
| Patient-reported outcomes | |||
| PRO-S—level of opioid-related problems (a) | |||
| Less than moderate—participants | 103 (66.0) | 99 (62.7) | 202 (64.3) |
| Moderate or more—participants | 53 (34.0) | 47 (36.7) | 111 (35.4) |
Data are n (%); mean (SD).
Missing data is: (a) 1 participant in the BUP-XR group; (b) 4 participants in the SoC group and 6 participants in the BUP-XR group; (c) 17 participants in the SoC group and 23 participants in the BUP-XR group; (d) 1 participant in the SoC group and 1 participant in BUP-XR group.
ADAPT, Addiction Dimensions for Assessment and Personalised Treatment; BUP-XR, extended-release buprenorphine; CUD, cocaine use disorder; CEQ-F, Craving Experiences Questionnaire-frequency version; DERS-SF, Difficulties in Emotion Regulation Scale-Short Form; GSI-S, Global Severity Index-Severity; OUD, opioid use disorder; VAS-N, visual analogue scale of perceived need for drug; VAS-W, visual analogue scale of perceived want for drug; PRO-S, patient rated evaluation of severity; SoC, standard-of-care; QIDS-SR, Quick Inventory of Depressive Symptomatology-Self-Report; WSAS, Work and Social Adjustment Scale.
Stratification variable.
Single case deviation, one participant commenced screening at 26 mg/day (2 mg/day above protocol) and was managed in sensitivity analysis.
UK standard unit contains 8 g ethanol.