多中心随机临床试验的理论基础和设计，该试验旨在研究一种针对共病慢性疼痛和阿片类药物使用障碍退伍军人的综合行为治疗方法：疼痛和阿片类药物综合治疗退伍军人（POSITIVE）试验。
Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial.
机构信息
School of Psychology, Queen's University Belfast, Belfast, Northern Ireland, UK.
Department of Psychology, University of New Mexico, Albuquerque, NM, USA.
出版信息
Contemp Clin Trials. 2023 Mar;126:107096. doi: 10.1016/j.cct.2023.107096. Epub 2023 Jan 21.
BACKGROUND
Chronic pain and opioid use disorder (OUD) individually represent a risk to health and well-being. Concerningly, there is evidence that they are frequently co-morbid. While few treatments exist that simultaneously target both conditions, preliminary work has supported the feasibility of an integrated behavioral treatment targeting pain interference and opioid misuse. This treatment combined Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (ACT+MBRP). This paper describes the protocol for the adequately powered efficacy study of this integrated treatment.
METHODS
A multisite randomized controlled trial will examine the efficacy of ACT+MBRP in comparison to a parallel education control condition, focusing on opioid safety and pain education. Participants include veterans (n = 160; 21-75 years old) recruited from three Veterans Administration (VA) Healthcare Systems with chronic pain who are on a stable dose of buprenorphine. Both conditions include twelve weekly 90 min group sessions delivered via telehealth. Primary outcomes include pain interference (Patient Reported Outcome Measurement Information System - Pain Interference) and hazardous opioid use (Current Opioid Misuse Measure), which will be examined at the end of the active treatment phase and through 12 months post-intervention. Secondary analyses will evaluate outcomes including pain intensity, depression, pain-related fear, and substance use, as well as treatment mechanisms.
CONCLUSION
This study will determine the efficacy of an integrated behavioral treatment program for pain interference and hazardous opioid use among veterans with chronic pain and OUD who are prescribed buprenorphine, addressing a critical need for more integrated treatments for chronic pain and OUD.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04648228.
背景
慢性疼痛和阿片类药物使用障碍（OUD）各自代表着对健康和福祉的风险。令人担忧的是，有证据表明它们经常同时存在。虽然很少有同时针对这两种疾病的治疗方法，但初步研究支持了针对疼痛干扰和阿片类药物滥用的综合行为治疗的可行性。这种治疗方法结合了接受和承诺疗法（ACT）和基于正念的复发预防（ACT+MBRP）。本文描述了这种综合治疗的充分功效研究的方案。
方法
一项多地点随机对照试验将比较 ACT+MBRP 与平行的教育对照条件的疗效，重点关注阿片类药物安全和疼痛教育。参与者包括来自三个退伍军人事务部（VA）医疗保健系统的慢性疼痛患者（n=160；21-75 岁），他们正在服用稳定剂量的丁丙诺啡。两种情况都包括十二周每周 90 分钟的小组会议，通过远程医疗进行。主要结果包括疼痛干扰（患者报告的结果测量信息系统-疼痛干扰）和危险的阿片类药物使用（当前阿片类药物滥用测量），将在积极治疗阶段结束时和干预后 12 个月进行评估。次要分析将评估包括疼痛强度、抑郁、与疼痛相关的恐惧和物质使用在内的结果，以及治疗机制。
结论
这项研究将确定针对服用丁丙诺啡的慢性疼痛和 OUD 退伍军人的疼痛干扰和危险阿片类药物使用的综合行为治疗计划的疗效，这是满足对慢性疼痛和 OUD 更综合治疗的迫切需求。
试验注册
ClinicalTrials.gov 标识符：NCT04648228。
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