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患者逐步护理以优化全面康复(SC-POWR):一项评估针对阿片类药物使用障碍和慢性疼痛患者的逐步护理模型的有效性试验。

Stepped Care for Patients to Optimize Whole Recovery (SC-POWR): An Effectiveness Trial Evaluating a Stepped Care Model for Individuals With Opioid Use Disorder and Chronic Pain.

作者信息

Rossi Raiza, Cutter Christopher J, Beitel Mark, Covelli Mikah, Fiellin David A, Kerns Robert D, Vassilieva Svetlana, Olabisi Deborah, Barry Declan T

机构信息

Internal Medicine, Yale School of Medicine, New Haven, CT, USA.

Yale Child Study Center, New Haven, CT, USA.

出版信息

Subst Use Addctn J. 2025 Jan;46(1):146-154. doi: 10.1177/29767342241245095. Epub 2024 Apr 12.

Abstract

Many patients who receive treatment for opioid use disorder (OUD) report experiencing chronic pain (CP), which is associated with high levels of ongoing nonmedical opioid use and low retention in OUD treatment. In pilot studies of patients with OUD receiving buprenorphine or methadone who had CP, cognitive behavioral therapy (CBT) attenuated nonmedical opioid use compared with treatment-as-usual (TAU), but patients in both treatment arms exhibited similar pain improvements. Adding exercise and stress reduction to this model may augment pain-related outcomes. With funding from National Institutes of Health, we plan to conduct a randomized clinical trial of 316 patients with OUD and CP to test the effectiveness of TAU compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce nonmedical opioid use and pain (primary outcomes) (Aim 1) and decrease pain intensity and interference, alcohol use, anxiety, depression and stress, and improve sleep (secondary outcomes) (Aim 2). Eligible participants will be randomized to receive TAU (buprenorphine or methadone and at least once a month individual or group counseling) or SC-POWR (ie, TAU and up to 12 CBT sessions) for 24 weeks. Based on prespecified nonresponse criteria, SC-POWR may be stepped up at week 6 to receive onsite weekly group sessions of exercise (Wii Fit, Tai Chi) and "stepped up" again at week 15 to receive weekly group sessions of stress reduction (relaxation training, auricular acupuncture). They will be followed for another 24 weeks to evaluate durability of treatment response for illicit opioid use, alcohol use, pain, anxiety, depression, stress, sleep, and retention in medications for OUD (Aim 3).

摘要

许多接受阿片类物质使用障碍(OUD)治疗的患者报告称患有慢性疼痛(CP),这与持续大量非医疗性使用阿片类物质以及在OUD治疗中的低留存率相关。在接受丁丙诺啡或美沙酮治疗且患有CP的OUD患者的试点研究中,与常规治疗(TAU)相比,认知行为疗法(CBT)减少了非医疗性阿片类物质的使用,但两个治疗组的患者在疼痛改善方面表现相似。在此模型中加入运动和减压措施可能会增强与疼痛相关的治疗效果。在获得美国国立卫生研究院的资助后,我们计划对316名患有OUD和CP的患者进行一项随机临床试验,以测试TAU与患者优化全面康复阶梯式护理(SC-POWR)相比在减少非医疗性阿片类物质使用和疼痛(主要结局)方面的有效性(目标1),以及在减轻疼痛强度和干扰、减少酒精使用、缓解焦虑、抑郁和压力以及改善睡眠(次要结局)方面的有效性(目标2)。符合条件的参与者将被随机分配接受TAU(丁丙诺啡或美沙酮以及每月至少一次的个体或团体咨询)或SC-POWR(即TAU以及最多12次CBT疗程),为期24周。根据预先设定的无反应标准,SC-POWR可能在第6周加强,接受每周一次的现场运动团体课程(Wii Fit、太极拳),并在第15周再次“加强”,接受每周一次的减压团体课程(放松训练、耳针疗法)。他们将再接受24周的随访,以评估治疗反应在非法阿片类物质使用、酒精使用、疼痛、焦虑、抑郁、压力、睡眠以及OUD药物留存率方面的持久性(目标3)。

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