Division of General Internal Medicine, Department of Medicine, University of Washington, Seattle, WA, 98104, USA.
Department of Biostatistics, University of Washington, Seattle, WA, USA.
Drug Alcohol Depend. 2021 Oct 1;227:108917. doi: 10.1016/j.drugalcdep.2021.108917. Epub 2021 Jul 28.
We conducted a pilot study to assess feasibility of using video directly-observed therapy (DOT) for patients initiating buprenorphine to evaluate whether it is associated with better opioid use disorder (OUD) outcomes when compared to treatment-as-usual (TAU).
Pilot randomized controlled trial of adult patients with OUD initiating buprenorphine treatment (n = 78) at two sites (Seattle, WA and Boston, MA) from January 2019 to May 2020. Intervention was video DOT using a HIPAA-compliant smartphone application to record taking daily buprenorphine. Study smartphones, text reminders to upload a video, and calendar summaries of video DOT adherence were provided. Main outcomes were 1) percentage of 12 weekly urine drug tests (UDT) negative for illicit opioids and 2) engagement in treatment at week 12 (i.e., having an active prescription for buprenorphine within the last 7 days).
Of 78 enrolled, 20 (26 %) were female; 29 (37 %) non-white; and 31 (40 %) homeless. The mean (standard deviation) percentage of doses confirmed by video was 31 % (34 %). In intention-to-treat analysis, the average percentage of weekly opioid negative UDT was 50 % (95 % CI: 40-63 %) in the intervention arm versus 64 % (95 % CI: 55-74 %) among controls; RR = 0.78 (95 % CI: 0.60-1.02, p = 0.07). Engagement at week 12 was 69 % (95 % CI: 56-86 %) v. 82 % (95 % CI: 71-95 %) in the intervention vs. TAU arms, respectively; RR = 0.84 (95 % CI: 0.65-1.10, p = 0.20).
The video DOT intervention did not result in improvements in illicit opioid use and treatment engagement compared to TAU. The study was limited by low rates of intervention use.
ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.
我们进行了一项试点研究，评估直接观察治疗（DOT）视频在开始使用丁丙诺啡的患者中的可行性，以评估与常规治疗（TAU）相比，它是否与更好的阿片类药物使用障碍（OUD）结果相关。
这是一项在两个地点（华盛顿州西雅图和马萨诸塞州波士顿）进行的试点随机对照试验，纳入了 2019 年 1 月至 2020 年 5 月期间开始接受丁丙诺啡治疗的 OUD 成年患者（n=78）。干预措施是使用符合 HIPAA 标准的智能手机应用程序记录每日丁丙诺啡的视频 DOT。提供了研究智能手机、上传视频的文本提醒以及视频 DOT 依从性的日历摘要。主要结局是 1）12 周每周尿液药物测试（UDT）中非法阿片类药物阴性的百分比，以及 2）12 周时的治疗参与率（即过去 7 天内有丁丙诺啡的有效处方）。
在 78 名入组患者中，有 20 名（26%）为女性；29 名（37%）为非白人；31 名（40%）无家可归。通过视频确认的剂量平均值（标准差）为 31%（34%）。意向治疗分析中，干预组每周阿片类药物阴性 UDT 的平均百分比为 50%（95%CI：40-63%），对照组为 64%（95%CI：55-74%）；RR=0.78（95%CI：0.60-1.02，p=0.07）。第 12 周时的参与率，干预组为 69%（95%CI：56-86%），对照组为 82%（95%CI：71-95%）；RR=0.84（95%CI：0.65-1.10，p=0.20）。
与 TAU 相比，视频 DOT 干预并未导致非法阿片类药物使用和治疗参与率的改善。该研究受到干预使用率低的限制。
ClinicalTrials.gov，NCT03779997，于 2018 年 12 月 19 日注册。
