Extended-release Pharmacotherapy for Opioid Use Disorder (EXPO): Protocol for an Open-label Randomised Controlled Trial of Injectable Maintenance Buprenorphine With Personalised Psychosocial Intervention.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 5
- 主要终点
- Count of days abstinent From illicit/non-medical opioids during weeks 2 to 24 (range: 0-161 days)
研究概览
简要总结
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)
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
XR-Bup
Extended-Release Buprenorphine, monthly, 300mg or 100mg
干预措施: Buprenorphine Injectable Product (Drug)
Bup/Met
Standard of Care; either Buprenorphine (including Subutex, Suboxone & Espranor) or Methadone (Participant Preference).
干预措施: Methadone (Drug)
Bup/Met
Standard of Care; either Buprenorphine (including Subutex, Suboxone & Espranor) or Methadone (Participant Preference).
干预措施: Buprenorphine (Drug)
XR-Bup + PSI
Extended-Release Buprenorphine, monthly, 300mg or 100mg + Personalised Psychosocial Intervention (PSI)
干预措施: Buprenorphine Injectable Product (Drug)
Bup/Met + PSI
Standard of Care; either Buprenorphine (including Subutex, Suboxone & Espranor) or Methadone (Participant Preference) + Personalised Psychosocial Intervention (PSI)
干预措施: Methadone (Drug)
Bup/Met + PSI
Standard of Care; either Buprenorphine (including Subutex, Suboxone & Espranor) or Methadone (Participant Preference) + Personalised Psychosocial Intervention (PSI)
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Count of days abstinent From illicit/non-medical opioids during weeks 2 to 24 (range: 0-161 days)
时间窗: 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.
次要结局
- Work and social adjustment: WSAS(24 weeks)
- Patient rating of OUD severity and improvement:(24 weeks)
- Cost-effectiveness of XR-BUP versus Bup and Met(24 weeks)
- 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)
- Clinical superiority of XR-Bup plus PSI versus Bup/Met plus PSI(24 weeks)
- 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)
- 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)
- Subjective recovery and improvement: SURE(24 weeks)
- Alcohol consumption: typical quantity and frequency: (ALC-QFM)(24 weeks)