Ilgen Mark, Blow Frederic, Piette John D, Goldstick Jason, Lewis Mandy, Priest William, Matharu Harshpreet, Bourgoise Michael, Young Chelsea, Ashe Doctor, Price Amanda, Lin Lewei Allison
Department of Psychiatry, University of Michigan School of Medicine, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, USA; Center for Clinical Management Research (CCMR), VA Ann Arbor Healthcare System, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, USA.
Department of Psychiatry, University of Michigan School of Medicine, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, USA; Center for Clinical Management Research (CCMR), VA Ann Arbor Healthcare System, 2800 Plymouth Road, Building 16, Ann Arbor, MI 48109, USA.
Contemp Clin Trials. 2025 Sep 17;158:108081. doi: 10.1016/j.cct.2025.108081.
People with opioid use disorder (OUD) often experience comorbid chronic pain, which complicates treatment of both conditions. Medications for opioid use disorders (MOUD), specifically buprenorphine, are the standard of care for OUD and can be helpful for pain; however, a major challenge to sustaining effectiveness has been limited retention in buprenorphine treatment. Prior research has highlighted the efficacy of psychosocial treatments for pain management; although, research remains limited on integrated approaches to improve OUD outcomes among people/patients with chronic pain. This randomized controlled trial, called the Persist Study, investigated whether a psychosocial pain management intervention (PPMI) was more effective than Enhanced Usual Care (EUC) for MOUD patients with chronic pain.
This was a randomized trial of remotely delivered PPMI vs EUC for adults receiving MOUD who have chronic pain. Our study recruited nationally from MOUD clinics and through targeted online advertisements. Target enrollment was 200 participants randomly assigned to either PPMI (n = 100) or EUC (n = 100) conditions. The PPMI consisted of eight 1-h sessions and the EUC included two 15-min sessions conducted over a 6-week timespan. Primary outcomes measured retention on buprenorphine over 3 months, whereas secondary outcomes measured longer-term MOUD retention, pain level, pain-related functioning, and frequency of substance use over 12 months.
The Persist Study tested a remotely delivered, manualized, psychosocial intervention for co-occurring chronic pain in patients prescribed buprenorphine treatment for OUD. Study results will inform efforts to improve retention and treatment outcomes among patients receiving MOUD who also have chronic pain.
This clinical trial has been registered with ClincialTrials.gov under ID NCT04433975.
患有阿片类药物使用障碍（OUD）的人常常同时患有慢性疼痛，这使得两种病症的治疗都变得复杂。用于治疗阿片类药物使用障碍的药物（MOUD），特别是丁丙诺啡，是治疗OUD的标准疗法，对疼痛也可能有帮助；然而，维持疗效的一个主要挑战是丁丙诺啡治疗的持续留存率有限。先前的研究强调了心理社会治疗在疼痛管理方面的疗效；尽管如此，关于改善慢性疼痛患者OUD治疗效果的综合方法的研究仍然有限。这项名为“持续研究”的随机对照试验，调查了心理社会疼痛管理干预（PPMI）对患有慢性疼痛的MOUD患者是否比强化常规护理（EUC）更有效。
这是一项针对接受MOUD且患有慢性疼痛的成年人的随机试验，比较远程提供的PPMI与EUC。我们的研究通过MOUD诊所进行全国招募，并通过有针对性的在线广告。目标招募人数为200名参与者，随机分配到PPMI组（n = 100）或EUC组（n = 100）。PPMI包括八个1小时的疗程，EUC包括在6周时间内进行的两个15分钟的疗程。主要结局指标是丁丙诺啡在3个月内的留存率，次要结局指标是12个月内的长期MOUD留存率、疼痛程度、与疼痛相关的功能以及物质使用频率。
“持续研究”测试了一种远程提供的、手册化的心理社会干预措施，用于同时患有慢性疼痛且正在接受丁丙诺啡治疗OUD的患者。研究结果将为改善同时患有慢性疼痛的MOUD患者的留存率和治疗效果的努力提供信息。
这项临床试验已在ClinicalTrials.gov上注册，标识符为NCT04433975。
