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

项目摘要 阿片类药物流行已成为美国健康和生存的最普遍威胁之一。 阿片类药物使用障碍（MOUD）的治疗是金标准治疗，有强有力的证据表明， 有效减少类阿片使用、类阿片过量风险和类阿片相关死亡。然而，保留和 坚持MOUD治疗，特别是丁丙诺啡（BUP），是令人沮丧的低;因此，新的，成本- 有效、可扩展的干预方法，以增加和维持BUP治疗的保留和依从性 是迫切需要的。在NIDA的支持下（R34 DA 033196），申请人在RCT中开发并评价了 以阿片类药物使用为目标的基于认知行为疗法的短信系统干预（TXT-CBT） 和药物依从性之间的关系。这一非常有希望的干预措施表明， 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的功效， 这些发现在HIV感染的酒精使用者中重复（R34 AA 022055）。当前的目标 研究的目的是调整和扩展这种方法，以解决MOUD治疗的保留和坚持。实现 因此，我们建议分两个阶段进行研究。在第一阶段：（i）TXT-CBT是适应，与用户和MOUD提供商的输入，以 解决保留和坚持BUP治疗的关键障碍，并将其传输到可扩展的，用户友好的 短信平台，以形成imFREE（互动式消息传递，以摆脱阿片类药物成瘾）;以及（ii）可用性 进行imFREE的测试（n=16）以准备有效性试验。在第二阶段，（一）有效性 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作用进行了评估， 随机对照试验比较imFREE与移动健康教育控制条件（mHealth艾德）， 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MAT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“发展 对物质使用障碍的有效治疗是可实施的和自我维持的，以及 最佳的行为策略，以促进药物治疗的依从性和改善药物治疗的结果。 与RFA的目标一致，imFREE建立在有效的基于SMS的TXT-CBT基础上 干预，内容涉及保留和遵守BUP，包括减轻风险因素 辍学生imFREE还针对减少阿片类药物的使用，具有通知社交和提供者支持联系人的功能 在面临治疗中止和/或复发和过量风险的其他指标时。提供支持 为了最大限度地提高BUP治疗的依从性，再加上预防复发的技能，imFREE可能会提供一个成本- 有效的，易于部署的OUD治疗和预防过量死亡的策略。

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.