Vermont Center on Behavior and Health, University of Vermont, Burlington.
Department of Psychiatry, University of Vermont, Burlington.
JAMA Netw Open. 2023 Sep 5;6(9):e2331910. doi: 10.1001/jamanetworkopen.2023.31910.
Expansion of opioid use disorder treatment is needed, particularly in rural communities.
To evaluate technology-assisted buprenorphine (TAB) efficacy (1) over a longer period than previously examined, (2) with the addition of overdose education, and (3) among individuals residing in rural communities.
DESIGN, SETTING, AND PARTICIPANTS: Two parallel, 24-week randomized clinical trials were conducted at the University of Vermont between February 1, 2018, and June 30, 2022. Participants were adults with untreated opioid use disorder from nonrural (trial 1) or rural (trial 2) communities. These trials are part of a programmatic effort to develop TAB protocols to improve treatment availability in underserved areas.
Within each trial, 50 participants were randomized to TAB or control conditions. Participants in the TAB group completed bimonthly visits to ingest medication and receive take-home doses via a computerized device. They received nightly calls via an interactive voice response (IVR) system, IVR-generated random call-backs, and iPad-delivered HIV, hepatitis C virus (HCV), and overdose education. Control participants received community resource guides and assistance with contacting resources. All participants received harm reduction supplies and completed monthly assessments.
The primary outcome was biochemically verified illicit opioid abstinence across monthly assessments. Secondary outcomes included self-reported opioid use in both groups and abstinence at bimonthly and random call-back visits, treatment adherence, satisfaction, and changes in HIV, HCV, and overdose knowledge among TAB participants.
Fifty individuals (mean [SD] age, 40.6 [13.1] years; 28 [56.0%] male) participated in trial 1, and 50 (mean [SD] age, 40.3 [10.8] years; 30 [60.0%] male) participated in trial 2. Participants in the TAB group achieved significantly greater illicit opioid abstinence vs controls at all time points in both trial 1 (85.3% [128 of 150]; 95% CI, 70.7%-93.3%; vs 24.0% [36 of 150]; 95% CI, 13.6%-38.8%) and trial 2 (88.0% [132 of 150]; 95% CI, 72.1%-95.4%; vs 21.3% [32 of 150]; 95% CI, 11.4%-36.5%). High abstinence rates were also observed at TAB participants' bimonthly dosing visits (83.0% [95% CI, 67.0%-92.0%] for trial 1 and 88.0% [95% CI, 71.0%-95.0%] for trial 2). Treatment adherence was favorable and similar between trials (with rates of approximately 99% for buprenorphine administration, 93% for daily IVR calls, and 92% for random call-backs), and 183 of 187 urine samples (97.9%) tested negative for illicit opioids at random call-backs. iPad-delivered education was associated with significant and sustained increases in HIV, HCV, and overdose knowledge.
In these randomized clinical trials of TAB treatment, demonstration of efficacy was extended to a longer duration than previously examined and to patients residing in rural communities.
ClinicalTrials.gov Identifier: NCT03420313.
需要扩大阿片类药物使用障碍治疗，特别是在农村社区。
评估技术辅助丁丙诺啡（TAB）的疗效（1）比以前检查的时间更长，（2）增加了过量教育，（3）在农村社区居住的个体中。
设计、地点和参与者：两项平行、24 周的随机临床试验于 2018 年 2 月 1 日至 2022 年 6 月 30 日在佛蒙特大学进行。参与者是来自非农村（试验 1）或农村（试验 2）社区的未经治疗的阿片类药物使用障碍成年人。这些试验是开发 TAB 方案以改善服务不足地区治疗可及性的计划努力的一部分。
在每个试验中，50 名参与者被随机分配到 TAB 或对照组。TAB 组的参与者每两个月进行一次就诊，以摄入药物并通过计算机设备携带回家剂量。他们通过交互式语音应答（IVR）系统、IVR 生成的随机回叫以及 iPad 提供的 HIV、丙型肝炎病毒（HCV）和过量教育接受夜间电话。对照组参与者获得社区资源指南并协助联系资源。所有参与者均获得减少伤害用品，并完成每月评估。
主要结果是每月评估中经生物化学验证的非法阿片类药物戒断。次要结果包括两组参与者的自我报告阿片类药物使用情况以及 TAB 组在双月和随机回叫就诊时的戒断情况、治疗依从性、满意度以及接受 TAB 治疗的参与者的 HIV、HCV 和过量知识的变化。
50 名参与者（平均[SD]年龄，40.6[13.1]岁；28[56.0%]男性）参加了试验 1，50 名参与者（平均[SD]年龄，40.3[10.8]岁；30[60.0%]男性）参加了试验 2。与对照组相比，TAB 组在两个试验中的所有时间点均实现了更高的非法阿片类药物戒断（试验 1：85.3%[150 人中有 128 人；95%CI，70.7%-93.3%；vs 24.0%[150 人中有 36 人；95%CI，13.6%-38.8%]；试验 2：88.0%[150 人中有 132 人；95%CI，72.1%-95.4%；vs 21.3%[150 人中有 32 人；95%CI，11.4%-36.5%]）。在 TAB 组的双月剂量就诊时也观察到高戒断率（试验 1 为 83.0%[95%CI，67.0%-92.0%]；试验 2 为 88.0%[95%CI，71.0%-95.0%]）。治疗依从性良好且两个试验之间相似（丁丙诺啡给药率约为 99%，每日 IVR 呼叫率为 93%，随机回叫率为 92%），187 份尿液样本（97.9%）在随机回叫时检测出非法阿片类药物呈阴性。iPad 提供的教育与 HIV、HCV 和过量知识的显著和持续增加相关。
在这些 TAB 治疗的随机临床试验中，与以前检查的时间相比，证明了疗效的延长，并且在农村社区居住的患者中也证明了疗效。
ClinicalTrials.gov 标识符：NCT03420313。
