Table 2.
SPIRIT schedule of enrolment, intervention, and assessments
| Study week | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Measure | B | R | 1 | 2 | 4 | 6 | 8 | 10 | 12 | 14 | 16 | 18 | 20 | 22 | 24 | W | E | 52 |
| Consent and screening | X | X | X | |||||||||||||||
| SCID-5-RV | X | X | X | X | ||||||||||||||
| LFT | X | X | X | X | X | |||||||||||||
| BUP-XR | X | X | X | X | X | X | X | |||||||||||
| SOC (BUP-SL or MET) | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
| TLFB | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||
| ALC-QFM | X | X | ||||||||||||||||
| VAS-N (H/C) | X | X | X | X | X | X | X | X | ||||||||||
| VAS-W (H/C) | X | X | X | X | X | X | X | X | ||||||||||
| CEQ-F (H/C) | X | X | X | X | X | X | X | X | ||||||||||
| MoCA | X | X | ||||||||||||||||
| QIDS-SR | X | X | X | X | ||||||||||||||
| DERS-SF | X | X | X | X | X | |||||||||||||
| WSAS | X | X | X | X | ||||||||||||||
| PHQ-15 | X | |||||||||||||||||
| PHQ-4 | X | |||||||||||||||||
| EQ-5D-5L | X | X | X | |||||||||||||||
| OSTQOL | X | |||||||||||||||||
| KCF | X | X | X | |||||||||||||||
| Qualitative interview #1 | X | |||||||||||||||||
| Qualitative interview #2 | X | |||||||||||||||||
| ADSUS | X | X | X | |||||||||||||||
| SURE | X | X | X | |||||||||||||||
| PRO-S | X | |||||||||||||||||
| PRO-I | X | X | X | |||||||||||||||
| ADAPT | X | X | X | X | ||||||||||||||
| CGI-S | X | |||||||||||||||||
| CGI-I | X | X | X | |||||||||||||||
| UDS | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||
| CONMED | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||
| Adverse event log | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||
| Research payments | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||
B baseline, R randomisation, W withdrawal, E extended BUP-XR study treatment; 52 interview #2, SCID-5-RV Structured Clinical Interview for DSM-5 disorders — research version, LFT liver function tests, BUP-XR extended-release buprenorphine, study IMP, SOC standard-of-care, study comparator, TLFB TimeLine Follow-Back, calendar-prompt interview, ALC-QFM alcohol — quantity, frequency, and maximum consumption, VAS-N (H/C) visual analogue scale of perceived need for heroin and cocaine, VAS-W (H/C) visual analogue scale of perceived want for heroin and cocaine, CEQ-F (H/C) Craving Experiences Questionnaire for heroin and cocaine, MoCA Montreal Cognitive Assessment, version 7.1 (baseline) and 7.2 (follow-up), QIDS-SR Quick Inventory of Depressive Symptomatology — Self-Report, DERS-SF Difficulties in Emotion Regulation Scale — Short Form, WSAS Work and Social Adjustment Scale, PHQ-15/4; Patient Health Questionnaire (15 items and 4 items), OSTQOL Opioid Substitution Treatment Quality of Life scale, KCF Clinical Keyworker Contact Form; Qualitative interview (1), conducted at South London among participants allocated to BUP-XR, BUP-XR with PSI and BUP-SL or MET with PSI, and in West-Midlands England, North-East England, and Tayside among participants allocated to BUP-XR; Qualitative interview (2), conducted at South London and North-East England, among participants receiving longer-term BUP-XR treatment; ADSUS Adult Service Use Schedule, SURE Service User Recovery Evaluation, PRO-S/I patient-reported outcome — severity and improvement, ADAPT Addiction Dimensions for Assessment and Personalised Treatment, CGI-S/I Clinical Global Impression — severity and improvement, UDS urine drug screen, CONMED concomitant medication, reviewed at weeks 4, 12, and 24; Research payments (baseline, 24, and ~52-week qualitative interview is GBP 20 to offset time and cover travel and transferred to prepaid card; clinical attendance at weeks 1, 2, 4, 8,10,12, 16,18, and 20 to complete research measures is GBP 10; brief completion of research measures at weeks 6, 14, and 22 is GBP 5