MySafeRx: An integrated mobile platform for buprenorphine adherence

 描述(申请人提供)：阿片类药物依赖是一个严重的公共卫生问题。与阿片类药物有关的过量死亡是与药物有关的过量用药的主要原因，在美国，每天有100多人死于药物过量。年轻人中丙型肝炎的感染率急剧上升。丁丙诺啡/纳洛酮(B/N)是一种可以防止阿片类药物过量并阻止非法阿片类药物兴奋的药物。B/N也避免了 阿片类药物的戒断，减少对药物的渴望。因此，每天服用B/N可减少复发并防止每天服用过量药物。B/N延长治疗可提高恢复率，并使患者继续接受治疗。当阿片类药物滥用者接受B/N治疗时，传播丙型肝炎和艾滋病毒的风险降低。坚持接受治疗很重要，因为辍学与复发和过量死亡的高风险有关。虽然许多阿片类药物依赖者在B/N治疗中取得稳定，但50%的人在第一年内复发或退出；B/N治疗失败与较年轻的年龄密切相关。每天服用B/N对于帮助年轻人继续接受治疗和避免复发至关重要。在一项对阿片依赖青年的研究中，每周至少服用B/N 5天的人中，93%的人在12周后仍在接受治疗，而依从性较低的参与者中只有57%。此外，当B/N处方的患者没有服用全部剂量时，他们可能会出售或与他人分享；这种转移令人担忧，并加剧了医生不愿治疗阿片类药物依赖的人。MySafeRx综合治疗平台在不稳定时期为阿片类药物依赖的脆弱成年人提供更高水平的护理，通过视频会议远程提供日常激励恢复支持，并通过安全的电子药片分发机监督B/N的自我管理。通过在危险时期提供这种更高水平的护理并确保每天服药，MySafeRx可以改善治疗并拯救生命。MySafeRx项目的目标是将文本消息提醒、安全的电子药丸组织者和每日远程简短的激励性恢复支持访问与B/N的监督自我管理的标准化协议相结合 视频会议。这种系统集成方法可以成为全国辅助治疗计划的基础，支持办公室阿片类药物治疗提供者和照顾脆弱患者。这项计划可以扩大边缘化、高危群体和那些生活在治疗资源最少地区的人获得B/N的机会。MySafeRx的核心理念是每天在患者最愿意参与治疗的服药时刻提供有针对性的激励性康复支持。我们将招募 70-96名脆弱、不稳定的阿片依赖患者(35岁)，来自佛蒙特州西南部的乡村医生，在丁丙诺啡诱导期间和治疗期间非法阿片类药物失效后招募患者。我们将进行一项试点试验，比较MySafeRx和标准护理在B/N依从率、阿片类药物使用和治疗保留方面的比率。

 DESCRIPTION (provided by applicant): Opioid Dependence is a serious public health issue. Opioid-related overdose deaths are the leading cause of drug-related overdose and more than 100 people die each day in the US due to drug overdose. Rates of Hepatitis C infections have increased dramatically among young adults. Buprenorphine/naloxone (B/N) is a medication that can prevent opioid overdose and block the ability to get high from illicit opioids. B/N also averts opioid withdrawal and decreases craving. Therefore, taking B/N daily reduces relapse and prevents overdose each day it is taken. Extended treatment with B/N increases rates of recovery and keeps people engaged in treatment. When an opioid abuser is in B/N treatment, the risk of transmitting Hepatitis C and HIV are reduced. Staying in treatment is important because dropout is associated with relapse and a high risk of overdose death. While many people with opioid dependence achieve stability in B/N treatment, 50% relapse or drop out within the first year; B/N treatment failure is strongly associated with younger age. Taking B/N every day can be critical for helping young people stay in treatment and avoid relapse. In a study of opioid dependent youth, 93% of those who took B/N at least 5 days each week were still in treatment after 12 weeks compared with only 57% of less adherent participants. Also, when patients prescribed B/N do not take their full dose, then they may sell it or share it with others; this diversion is worrisome and intensifies physician reluctance to treat people with opioid dependence. The MySafeRx integrative therapy platform provides a higher level of care for vulnerable adults with opioid dependence during periods of instability by providing daily motivational recovery support delivered remotely via videoconference in combination with supervised self-administration of B/N from a secure electronic pill dispenser. By offering this higher level of care during risky periods and ensuring daily medication-taking, MySafeRx could improve treatment and save lives. The goal of the MySafeRx project is to integrate text messaging reminders, secure electronic pill organizers, and daily remote brief motivational recovery support visits with a standardized protocol for supervised self- administration of B/N via videoconferencing. This systems integration approach could become the foundation for a nationwide adjunctive treatment program supporting office-based opioid treatment providers and caring for vulnerable patients. This program could expand access to B/N for marginalized, high-risk groups and those living in areas with minimal treatment resources. Providing targeted motivational recovery support each day at the moment of medication-taking when patients are most receptive to participating in treatment is central to the concept of MySafeRx. We will recruit 70-96 vulnerable, unstable opioid dependent patients (<35 years old) from rural physician practices in Southwest Vermont by enrolling patients during buprenorphine induction and after illicit opioid lapse during treatment. We will conduct a pilot trial comparing MySafeRx versus standard care on rates of B/N adherence, opioid use, and treatment retention.