Extended-release Pharmacotherapy for Opioid Use Disorder
- Conditions
- Opiate Substitution Treatment
- Interventions
- Registration Number
- NCT05164549
- Lead Sponsor
- King's College London
- Brief Summary
The primary objective is a clinical superiority effectiveness contrast to standard of care. Reported following SPIRIT and CONSORT standards, the study will determine whether extended-release injectable depot Buprenorphine (XR-Bup) maintenance therapy for OUD over six months is clinically superior to standard-of-care, oral medication (sublingual Buprenorphine \[SL-Bup\] or oral methadone \[Met\]; together: Bup/Met)
- Detailed Description
EXPO is a pragmatic, multi-centre, open label, four-arm, parallel group, superiority RCT, with a qualitative (mixed-methods) evaluation. The objective of the study is to determine the effectiveness and cost-effectiveness of XR-BUP versus SOC SL-BUP or MET. The primary study endpoint is six months of study treatment. EXPO also contains a single-site evaluation of the effectiveness of XR-BUP with adjunctive PSI versus SOC with adjunctive PSI. Participants allocated to XR-BUP can request to receive longer-term treatment for the duration of the study.
The study population is adults (≥18 years) enrolled in standard-of-care medication treatment for OUD. The study setting is specialist community addiction treatment programmes operated by the National Health Service in England and Scotland. There will be five participant treatment sites in South-East England (South London); North-East England (Newcastle); West Midlands, England (Solihull and Wolverhampton); North-West England (Manchester), and Tayside, Scotland (Dundee).
Groups
In all sites, participants will be randomly allocated to one of two groups:
Group 1. Injectable medication for OUD for 24 weeks (XR-BUP; the experimental condition) Group 2. Oral medication for OUD for 24 weeks (SL-BUP or MET; the control condition).
At the EXPO co-ordinating centre in South London, there will also be random allocation of participants to two additional groups, as follows:
Group 3. Injectable medication for OUD with adjunctive PSI for 24 weeks (XR-BUP with PSI; the experimental condition)
Group 4. Oral medication for OUD with adjunctive PSI for 24 weeks (SL-BUP or MET with PSI; the control condition).
Study aims
Across 24-weeks of study treatment, the primary aim of the EXPO study is to determine:
1. The effectiveness and cost-effectiveness of XR-BUP versus SL-BUP or MET; and
2. The effectiveness of XR-BUP with PSI versus SL-BUP or MET with PSI.
Across 24-weeks of study treatment, secondary study aims will determine the:
1. Safety of XR-BUP;
2. Retention of XR-BUP; SL-BUP; MET; XR-BUP with PSI; and SL-BUP or MET with PSI;
3. Effectiveness of XR-BUP and SL-BUP and MET to reduce opioid craving;
4. Effectiveness of XR-BUP; SL-BUP; MET; XR-BUP with PSI; SL-BUP with PSI; and MET with PSI to reduce use of heroin, cocaine, and benzodiazepines;
5. Effectiveness of XR-BUP and SL-BUP and MET to improve social functioning and recovery.
6. Cost-effectiveness of XR-BUP versus SL-BUP and MET, based on the incremental cost per quality-adjusted life year (QALY) gained.
Study aims will be evaluated by following a pre-registered statistical and health economic analysis plan.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 342
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bup/Met Methadone Standard of Care; either Buprenorphine (including Subutex, Suboxone \& Espranor) or Methadone (Participant Preference). XR-Bup Buprenorphine Injectable Product Extended-Release Buprenorphine, monthly, 300mg or 100mg XR-Bup + PSI Buprenorphine Injectable Product Extended-Release Buprenorphine, monthly, 300mg or 100mg + Personalised Psychosocial Intervention (PSI) Bup/Met Buprenorphine Standard of Care; either Buprenorphine (including Subutex, Suboxone \& Espranor) or Methadone (Participant Preference). Bup/Met + PSI Methadone Standard of Care; either Buprenorphine (including Subutex, Suboxone \& Espranor) or Methadone (Participant Preference) + Personalised Psychosocial Intervention (PSI) Bup/Met + PSI Buprenorphine Standard of Care; either Buprenorphine (including Subutex, Suboxone \& Espranor) or Methadone (Participant Preference) + Personalised Psychosocial Intervention (PSI)
- Primary Outcome Measures
Name Time Method Count of days abstinent From illicit/non-medical opioids during weeks 2 to 24 (range: 0-161 days) 24 weeks Combining self-report information from Time-Line Follow-Back interview adapted from the Treatment Outcomes Profile and incorporating data from 12 scheduled urine drug screens.
- Secondary Outcome Measures
Name Time Method Subjective recovery and improvement: SURE 24 weeks Work and social adjustment: WSAS 24 weeks Patient rating of OUD severity and improvement: 24 weeks Cognitive impairment: MoCA
Cost-effectiveness of XR-BUP versus Bup and Met 24 weeks Based on the incremental cost per quality-adjusted life year (QALY) gained.
Time (days) enrolled in study treatment (retention) to week 24 24 weeks Frequency of opioid (H) and cocaine (C) craving experience: CEQ-F(H) and CEQ-F(C) 24 weeks Difficulties in Emotion Regulation (Short Form): DERS-SF 24 weeks Longer Term Outcomes Through study completion, up to 4 years Among participants enrolled in longer term XR-BUP treatment: quality of life (OSTQOL)
Clinical superiority of XR-Bup plus PSI versus Bup/Met plus PSI 24 weeks Number of days abstinent from cocaine Days 8 - 168 Number of days abstinent from Benzodiazepines Days 8 - 168 Longest time in days continuously abstinent from heroin Days 8 - 168 Longest time in days continuously abstinent from cocaine Days 8 - 168 Longest time in days continuously abstinent from Benzodiazepines Days 8 - 168
OUD remission status (DSM5 OUD severity; SCID-5-RV) 24 weeks Craving need and want strength for heroin and cocaine: VAS-N(H/C) and VAS-W(H/C) 24 weeks Safety of XR-Bup 24 weeks Number of safety events from study enrolment to 24 weeks
Depression symptoms: QIDS-SR 24 weeks Clinician rating of severity, complexity and recovery strengths: ADAPT 24 weeks Clinician global impression of severity and improvement): CGI-S/I; 24 weeks Count of days abstinent from cocaine and illicit/non-medical benzodiazepines 24 weeks During weeks 2 to 24 (range: 0-161 days); combining self-report information from Time-Line Follow-Back interview adapted from the Treatment Outcomes Profile and incorporating data from 12 scheduled urine drug screens
Alcohol consumption: typical quantity and frequency: (ALC-QFM) 24 weeks
Trial Locations
- Locations (5)
South London and Maudsley NHS Foundation Trust
🇬🇧London, United Kingdom
NHS Tayside
🇬🇧Dundee, United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, United Kingdom
Birmingham and Solihull Mental Health NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
🇬🇧Manchester, United Kingdom