Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, United States of America.
Johns Hopkins University School of Medicine, 911 North Broadway, Baltimore, MD 21205, United States of America.
J Subst Abuse Treat. 2021 Feb;121:108197. doi: 10.1016/j.jsat.2020.108197. Epub 2020 Nov 24.
Covid-19 confers substantial risk for the >400,000 patients who receive methadone for the treatment of opioid use disorder (OUD) and methods for safely dispensing large quantities of methadone to patients are lacking.
This study evaluated the MedMinder "Jon", an electronic and cellular-enabled pillbox that provides real-time monitoring to remotely manage take-home doses of methadone using a 12-week, within-subject, Phase II (NCT03254043) trial. We transitioned all participants from liquid to tablet methadone one week prior to randomization. Participants completed both treatment-as-usual and electronic pillbox conditions before choosing a condition in a final "choice phase". We assessed feasibility, satisfaction, and safety outcomes during the exit interview.
Overall, we randomized 25 participants, 24 (96.0%) completed >1 study session, and 21 (84.0%) completed the exit interview. We dispensed 167.92 g (1,974 doses) of methadone. Participants would use the pillbox again (86.3%) and recommend it to others (95.4%). Overall, 52.4% selected the pillbox in the choice condition and those who did not cited issues related to study requirements. Less than 1% of pillbox alerts were for medication being consumed outside the dosing window and we observed no evidence of actual or attempted methadone diversion.
We were able to adequately manage patients who would not otherwise qualify for large quantities of take-home methadone when we dispensed methadone tablets via a secure pillbox. The integration of a commercially available pillbox into routine clinic operations increases opportunity for dispensing medication. Our data support remote monitoring of methadone take-home doses and may inform clinic practices related to Covid-19.
新冠病毒对接受美沙酮治疗阿片类药物使用障碍(OUD)的>400,000 名患者构成了巨大风险,而缺乏安全分发大量美沙酮给患者的方法。
本研究评估了 MedMinder“Jon”,这是一种电子和蜂窝启用的药盒,通过 12 周的、个体内的、二期(NCT03254043)试验,使用实时监测来远程管理美沙酮的带回家剂量。在随机分组前一周,我们将所有参与者从液体美沙酮转换为片剂美沙酮。参与者在最后一个“选择阶段”中选择条件之前,完成了常规治疗和电子药盒两种条件。我们在退出访谈中评估了可行性、满意度和安全性结果。
总体而言,我们随机分配了 25 名参与者,24 名(96.0%)完成了>1 次研究会议,21 名(84.0%)完成了退出访谈。我们分发了 167.92 克(1974 剂)美沙酮。参与者会再次使用药盒(86.3%)并推荐给他人(95.4%)。总体而言,在选择条件下,有 52.4%的参与者选择了药盒,而没有选择的参与者则提到了与研究要求相关的问题。少于 1%的药盒提醒是药物在给药窗口外被消耗,我们没有发现实际或试图转移美沙酮的证据。
当我们通过安全药盒分发美沙酮片剂时,我们能够为那些否则不符合大量带回家美沙酮条件的患者提供足够的管理。将市售药盒整合到常规诊所运营中增加了分发药物的机会。我们的数据支持远程监测美沙酮带回家的剂量,并可能为与新冠病毒相关的诊所实践提供信息。