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

针对 MOUD 保留、依从性和阿片类药物使用的基于 CBT 的移动医疗干预措施的有效性

• 批准号: 10358798
• 负责人: Suzette V Glasner-Edwards
• 金额: $ 79.41万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-28 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10358798
• 关键词: Address; Adherence; Adult; Affect; Aftercare; Alcohols; Anti-Retroviral Agents; Behavior Therapy; Behavioral; Behavioral Research; Biochemical; Buprenorphine; Car Phone; Cellular Phone; Cognitive Therapy; Communities; Cost Effectiveness Analysis; Cost Measures; Coupled; Data; Development; Dropout; Education; Educational Intervention; Effectiveness; Evaluation; Feedback; Freedom; Gold; HIV; Health; Health education; Individual; Intervention; Interview; Investigation; Measures; Medical; National Institute of Drug Abuse; Opiate Addiction; Outcome; Participant; Pharmaceutical Preparations; Pharmacotherapy; Phase; Population; Preparation; Process; Protocols documentation; Provider; Public Health; Relapse; Reporting; Research; Research Design; Research Personnel; Risk Factors; Site; Subgroup; Substance Use Disorder; System; Technology; Testing; Text Messaging; addiction; base; buprenorphine treatment; cost; cost effective; cost-effectiveness evaluation; effective intervention; effective therapy; effectiveness evaluation; effectiveness testing; effectiveness trial; efficacious treatment; experience; family support; follow-up; health service use; implementation facilitation; improved; improved outcome; innovation; intervention participants; low socioeconomic status; mHealth; medication compliance; medication-assisted treatment; novel; opioid epidemic; opioid mortality; opioid overdose; opioid use; opioid use disorder; opioid user; overdose death; overdose prevention; overdose risk; phase 2 study; prescription opioid; prevent; primary outcome; programs; psychosocial; recruit; relapse risk; response; skills; social; social interventions; standard care; substance user; tool; treatment adherence; usability; user-friendly

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.

项目摘要 阿片类药物流行已成为美国药物对健康和生存最普遍的威胁之一 对于治疗阿片类药物使用障碍（MOUD）是金标准治疗，有强有力的证据表明 减少阿片类药物使用，阿片类药物过量风险和与阿片类药物相关的死亡的有效性。然而，保留和 遵守MOUD治疗，尤其是丁丙诺啡（BUP），令人沮丧地低。因此，新颖，成本 - 有效的，可扩展的干预方法，以增加和维持保留和遵守BUP治疗 迫切需要。在NIDA支持（R34 DA033196）的情况下，适用于RCT开发和评估 基于认知行为疗法的短消息系统（SMS）干预（TXT-CBT）针对OID的使用 和艾滋病毒的阿片类药物用户的药物依从性。这种备受承诺的干预措施证明了 减少阿片类药物使用和增加生化验证的抗逆转录病毒药物依从性的功效， 在感染HIV的酒精使用者中复制的发现（R34 AA 022055）。电流的目的 研究是为了适应和扩展这种方法来解决MOUD治疗保留和依从性。实现 这是我们提出的2阶段研究。在第I阶段：（i）TXT-CBT已与用户和MOUD提供商输入一起调整为 解决保留和遵守BUP治疗的关键障碍，并运输到可扩展的，用户友好的障碍 SMS平台，形成IMFREE（用于免受阿片类药物成瘾的自由的交互式消息）； （ii）可用性 进行Imfree的测试（n = 16）为有效试验做准备。在第二阶段，（i）有效性 在改善BUP治疗保留和依从性和降低阿片类药物中的无效的评估 RCT将IMFRE与MHealth教育控制条件（MHealth ED）进行比较 启动BUP，（ii）我们评估Imfree的成本效益。该应用程序非常适合 对RFA-19-006的反应，“改善MAT的行为研究：改善行为和社会干预措施 遵守药物辅助治疗阿片类药物使用障碍，这鼓励“发展 实施和自我维持的物质使用障碍的有效治疗 最佳的行为策略，以促进药物依从性并改善药物治疗的预后。” 与RFA的目标一致，基于高效的S​​MS TXT-CBT构建 干预措施，内容解决了保留和遵守BUP的依据，包括减轻风险因素 辍学。 Imfree还针对阿片类药物的使用减少，并具有通知社交和提供者支持联系人的功能 面对治疗中断和/或其他救济和过量风险的指标。通过提供支持 为了最大化BUP治疗依从性，再加上防止退休的技能，Imfree可能会提供成本 - 有效，易于部署的策略，以治疗和预防过量死亡。