Effectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use

项目摘要 阿片类药物的流行已经成为美国药物治疗中对健康和生存最普遍的威胁之一。 治疗阿片使用障碍(MOUD)是黄金标准治疗，有强有力的证据表明 在减少阿片类药物使用、阿片类药物过量风险和阿片类药物相关死亡方面的有效性。然而，留存和 对Moud治疗的依从性，特别是丁丙诺啡(BUP)，低得令人沮丧；因此，新的成本- 有效、可扩展的干预方法，以增加和维持对BUP治疗的保留和坚持 都是迫切需要的。在NIDA的支持下(R34 DA033196)，申请人在RCT中开发和评估了 针对阿片类药物使用的基于认知行为疗法的短信系统干预(TXT-CBT) 以及感染艾滋病毒的阿片类药物使用者的用药依从性。这一极有希望的干预行动证明了 在减少阿片类药物使用和增加经生化验证的抗逆转录病毒药物依从性方面的有效性， 在感染艾滋病毒的酒精使用者中重复了这一发现(R34 AA 022055)。当前的目标是 研究是为了适应和推广这一方法，以解决Moud治疗保留和依从性问题。要实现 为此，我们提出了一个分两个阶段的研究。在第一阶段，：(I)利用用户和Moud提供商的输入，对TXT-CBT进行调整，以 解决保留和遵守BUP治疗的关键障碍，并将其传输到可扩展、用户友好的 短信平台，以形成imFREE(摆脱阿片成瘾的互动消息传递)；以及(Ii)可用性 对imFREE进行测试(n=16)，为有效性试验做准备。在第二阶段，(I)成效 ImFREE在改善BUP治疗保留和依从性以及减少阿片类药物使用方面的评价 将imFREE与mHealth教育控制条件(MHealth ED)在符合以下条件的个人中进行RCT比较 启动BUP，以及(Ii)我们评估imFREE的成本效益。此应用程序非常适合作为 对RFA-19-006的回应，“改善MAT的行为研究：改善的行为和社会干预 坚持阿片类药物使用障碍的药物辅助治疗，这鼓励了这一发展 对可实施和自我维持的物质使用障碍的有效治疗，以及 促进服药依从性和改善药物治疗结果的最佳行为策略。“ 与RFA的目标一致，imFREE建立在有效的基于短信的TXT-CBT基础上 干预措施，内容涉及保留和遵守BUP，包括降低 辍学。ImFREE还针对减少阿片类药物的使用，提供通知社交和提供者支持联系人的功能 面对停止治疗和/或复发和过量用药风险的其他指标。通过提供支持 为了最大限度地坚持BUP治疗，再加上防止复发的技能，imFREE可能会提供一种成本- 有效、易于部署的治疗和预防过量死亡的战略。

Project Abstract The opioid epidemic has become one of the most pervasive threats to health and survival in the U.S. Medications for the treatment of opioid use disorders (MOUD) are the gold standard treatment, with robust evidence of effectiveness in reducing opioid use, opioid overdose risk and opioid-related deaths. Nevertheless, retention and adherence to MOUD treatment, particularly buprenorphine (BUP), are discouragingly low; as such, novel, cost- effective, scalable intervention approaches to increase and sustain retention and adherence to BUP treatment are urgently needed. With NIDA support (R34 DA033196), the applicant developed and evaluated, in a RCT, a cognitive behavioral therapy-based short message system (SMS) intervention (TXT-CBT) targeting opioid use and medication adherence among opioid users with HIV. This highly promising intervention demonstrated efficacy in reducing opioid use and increasing biochemically-verified antiretroviral medication adherence, findings that were replicated among HIV-infected alcohol users (R34 AA 022055). The objective of the current research is to adapt and extend this approach to address MOUD treatment retention and adherence. To achieve this, we propose a 2-phase study. In Phase I,: (i) TXT-CBT is adapted, with user and MOUD provider input, to address critical barriers to retention and adherence to BUP treatment, and transported to a scalable, user-friendly SMS platform, to form imFREE (Interactive Messaging for Freedom from Opioid Addiction); and (ii) Usability testing of imFREE is conducted (n=16) in preparation for an effectiveness trial. In Phase II, (i) the effectiveness of imFREE in improving BUP treatment retention and adherence and decreasing opioid use is evaluated in an RCT comparing imFREE to an mHealth education control condition (mHealth ED) among individuals who are initiating BUP, and (ii) we evaluate the cost-effectiveness of imFREE. This application is an excellent fit as a response to RFA-19-006, “Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatments for Opioid Use Disorders,” which encourages “the development of efficacious treatments for substance use disorders that are implementable and self-sustaining, as well as optimal behavioral strategies to promote medication adherence and improve outcomes of pharmacotherapies.” Consistent with the objectives of the RFA, imFREE builds upon the efficacious SMS-based TXT-CBT intervention, with content addressing retention and adherence to BUP, including mitigating risk factors for dropout. imFREE also targets decreased opioid use, with features to notify social and provider support contacts in the face of treatment discontinuation and/or other indicators of relapse and overdose risk. By providing support to maximize BUP treatment adherence, coupled with skills to prevent relapse, imFREE may provide a cost- effective, easily deployable strategy for OUD treatment and prevention of overdose deaths.