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Table 2 SPIRIT schedule of enrolment, intervention, and assessments

From: Extended-release pharmacotherapy for opioid use disorder (EXPO): protocol for an open-label randomised controlled trial of the effectiveness and cost-effectiveness of injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone

 

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

  1. 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
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Trials

ISSN: 1745-6215