Treating Polysubstance Use in Methadone Maintenance: Application of Novel Digital Technology

摘要 美沙酮是一种治疗阿片类药物使用障碍(OUD)的高效药物，但许多患者 过早地离开治疗，使他们面临复发和过量服药的高风险。广泛性 研究表明，并存可卡因的使用与美沙酮的滞留不良有关 治疗。这项拟议的研究将检验一种旨在改善 服用阿片类药物和可卡因的人群中美沙酮治疗滞留和其他结果 多物质使用。该设计是一项双臂随机对照试验，试验对象为一名患者。 进入美沙酮治疗后的一年内。留存(主要)和吸毒(次要) 美沙酮照常治疗(TAU，n=120)的结果将与添加 DynamiCare健康应急管理应用程序(TAU+DCM，n=120)。DCM是一种个人 数字治疗工具以应用程序的形式提供在患者的智能手机上。它的主要特征是 以方便、远程和全面的方式提供循证应急管理治疗 自动化方式，确保目标行为的有效性和奖励发放的即时性。 与保留相关的两个目标行为将是DCM计划的主要重点：1) 通过远程口腔液测试证实戒除鸦片类药物和可卡因，以及2)药物治疗 从美沙酮计划中拿到的，已经被临床记录证实了。TAU+DCM的参与者 ARM将在一年内实现这些预定的行为目标，并获得经济奖励 48周干预期。对所有参与者的全面评估将在 基线、3、6和12个月。目的1：确定TAU+DCM的相对有效性 与单用TAU相比，在12个月后改善美沙酮治疗的滞留率 治疗入口。目的2：确定TAU+DCM与TAU的相对有效性 仅在[目标2a]减少阿片类药物使用和可卡因使用方面；和[目标2b]改善其他 次要结果包括非定向药物使用和12年内的生活质量- 治疗后数月入院。目标3：探索应用程序的使用模式、可接受性和感知 通过治疗后12个月进入的个性化治疗干预的价值。 创新在于CM交付的平台和结构，以确保治疗保真度 无需临床参与即可实现远程行为监控和奖励发放的自动化 工作人员。该项目代表了数字疗法的一种新应用，以增强 多物质治疗的有效性。这个项目的发现可以改进 通过确定有效和可推广的美沙酮治疗对公众健康的影响 在治疗中断风险较高的患者中解决多物质使用问题的方法。

Abstract Methadone is a highly effective treatment for opioid use disorder (OUD), but many patients leave treatment prematurely, placing them at high risk of relapse and overdose. Extensive research shows that comorbid cocaine use is associated with poor retention in methadone treatment. The proposed study will examine a novel intervention designed to improve methadone treatment retention and other outcomes among people with opioid and cocaine polysubstance use. The design is a 2-arm randomized controlled trial conducted over a one- year period following methadone treatment entry. Retention (primary) and drug use (secondary) outcomes for methadone treatment as usual (TAU, n=120) will be compared with the addition of the DynamiCare Health Contingency Management app (TAU+DCM, n=120). DCM is a personal digital therapy tool provided as an app on the patient’s smart phone. Its central feature is the delivery of evidence-based contingency management therapy in a convenient, remote, and fully automated fashion that ensures validity of target behaviors and immediacy of reward delivery. Two target behaviors relevant to retention will be the primary focus of the DCM program: 1) abstinence from opiates and cocaine as verified via remote oral fluid testing, and 2) medication pickup from the methadone program as verified by clinic records. Participants in the TAU+DCM arm will receive financial rewards for achieving these pre-determined behavioral targets over a 48-week intervention period. Comprehensive assessment of all participants will be conducted at baseline, 3-, 6- and 12-months. Aim 1: To determine the relative effectiveness of TAU+DCM compared to TAU alone in improving methadone treatment retention through 12-months post treatment entry. Aim 2: To determine the relative effectiveness of TAU+DCM compared to TAU alone in terms of [AIM 2a] reducing opioid use and cocaine use; and [Aim 2b] improving other secondary outcomes including non-targeted substance use and quality of life through 12- months post treatment entry. Aim 3: To explore app use patterns, acceptability, and perceived value of the personalized treatment intervention through 12-months post treatment entry. Innovation lies in the platform and structure of CM delivery that ensures treatment fidelity with automation of remote behavioral monitoring and reward delivery without involvement of clinical staff. This project represents a novel application of digital therapeutics to enhance the effectiveness of OUD treatment with polysubstance use. Findings from this project can improve the public health impact of methadone treatment by identifying an effective and scalable approach to address polysubstance use among patients at heightened risk of treatment dropout.