改善阿片类药物使用障碍治疗结果的社会心理疼痛管理研究：随机对照试验方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-09-17 DOI:10.1016/j.cct.2025.108081

Mark Ilgen , Frederic Blow , John D. Piette , Jason Goldstick , Mandy Lewis , William Priest , Harshpreet Matharu , Michael Bourgoise , Chelsea Young , Doctor Ashe , Amanda Price , Lewei (Allison) Lin

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引用次数: 0

摘要

背景：阿片类药物使用障碍（OUD）患者经常经历共病性慢性疼痛，这使两种疾病的治疗复杂化。阿片类药物使用障碍（mod）的药物，特别是丁丙诺啡，是OUD的标准护理，可以帮助缓解疼痛；然而，持续有效的一个主要挑战是丁丙诺啡治疗的有限保留。先前的研究强调了心理社会治疗对疼痛管理的有效性；然而，关于改善慢性疼痛患者的OUD结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）是否比增强常规护理（EUC）对慢性疼痛的mod患者更有效。方法：这是一项随机试验，远程交付PPMI与EUC对患有慢性疼痛的成人接受mod。我们的研究在全国范围内从mod诊所和有针对性的在线广告中招募人员。目标入组为200名参与者，随机分配到PPMI （n = 100）或EUC （n = 100）组。PPMI包括八个1小时的疗程，EUC包括两个15分钟的疗程，为期6周。主要结果测量了丁丙诺啡在3个 月内的保留率，而次要结果测量了12个 月内的长期mod保留率、疼痛水平、疼痛相关功能和药物使用频率。讨论：Persist研究测试了远程递送、人工操作、社会心理干预对开具丁丙诺啡治疗OUD患者并发慢性疼痛的效果。研究结果将为改善同时患有慢性疼痛的mod患者的保留和治疗结果提供信息。试验注册：该临床试验已在ClincialTrials.gov注册，ID为NCT04433975。

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The psychosocial pain management to improve opioid use disorder treatment outcomes study: Protocol for a randomized controlled trial

Background

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.

Methods

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.

Discussion

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.

Trial registration: This clinical trial has been registered with ClincialTrials.gov under ID NCT04433975.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.