Assessing the Clinical and Cost-Effectiveness of a Virtual PEth-based Contingency Management for Adults with AUD

项目摘要/摘要 2020年，2830万美国人经历了酒精使用障碍(AUD)；但其中只有25%的人患有酒精使用障碍 接受了治疗。在大流行期间，60%的药物使用障碍患者报告说 以远程医疗为基础的成瘾护理。转向远程医疗提供了克服这些障碍的机会 影响亲身护理的获取和保留(例如，不便、耻辱)。在应急管理中 (Cm)，人们收到有形的增强剂，以换取提交生物样本来核实禁欲。厘米 是远程保健服务的理想选择，对远程保健模型的初步研究表明，酒精使用减少。在… 同时，这些模型也有局限性。他们需要佩戴透皮监测仪或提交多个 每天的呼气样本。因此，这些方法成本高昂、负担沉重，而且带有污名化色彩，这限制了它们的 可行性。部分由于这些生物标志物的限制，目前的CM模型很简短，平均约12周， 尽管有证据表明，更长的CM干预会导致更好的治疗后结果。因此， 我们研究计划的总体目标是利用磷脂酰乙醇(Peth)，这是一种基于血液的生物标记物 它可以检测到长达28天的酒精使用，以提供可行的基于远程健康的26周CM干预。在……里面 作为一项试点试验，我们开发了一种基于远程健康的PEH CM干预，参与者使用医疗设备， 在研究人员的观察下，Tasso-M20自行采集血液进行心跳试验。这 干预使用了两个阶段的方法，降低了心跳试验和强化的频率 从每周一次，到参与者达到一致的佩斯水平后不到每四周一次 禁欲2-4周(&lt；20 ng/ml)。71%的CM参与者达到了&>4周 戒断率为21%的照常治疗(TAU)组和43%的CM参与者达到了24 禁食几周后，TAU组的禁酒率为0%(p&lt；0.05)。基于这些有希望的结果，我们现在 建议在通过在线招募的200名患有AUD(n=200)的成年人样本中测试我们基于远程医疗的CM模型 通过将个体随机分成6个月的平台1)针对AUD的在线认知行为疗法 (CBT4CBT)和基于远程健康的CM(CM情况)或2)CBT4CBT和用于提交血液的增强剂 样本(不需要禁欲)(对照条件)。我们将评估peth定义的组内差异 禁酒和经常过量饮酒(每毫升200纳克)，以及与酒精有关的危害(如吸烟、吸毒 使用)。我们将通过在12个月的随访中评估结果来解决CM研究中的重要差距，这 比大多数以前的CM研究要长得多；使用概念模型来确定治疗后的预测因素 禁欲。我们模型推广的主要障碍是peth测试和CM增强剂的成本。 我们将进行经济分析，将这些成本放在下游CM相关成本的背景下- 抵消和改善个人和公共健康。如果我们的模式增加了酒精禁欲，而且成本很高- 它可以有效地惠及数百万无法或不寻求面对面护理的澳元美国人。

PROJECT SUMMARY/ABSTRACT In 2020, 28.3 million Americans experienced an alcohol use disorder (AUD); yet only 25% of these people received treatment. During the pandemic, 60% of patients with a substance use disorder reported receiving telehealth-based care for their addiction. The pivot to telehealth provides an opportunity to overcome the barriers to access and retention that affect in-person care (e.g., inconvenience, stigma). In contingency management (CM), people receive tangible reinforcers in exchange for submitting biological samples to verify abstinence. CM is ideal for telehealth delivery and initial studies of telehealth models demonstrated reductions in alcohol use. At the same time, these models have limitations. They require wearing a transdermal monitor or submitting multiple breath samples daily. As a result, these approaches are costly, burdensome, and stigmatizing which limits their feasibility. In part due to limitations of these biomarkers, current CM models are brief, averaging about 12 weeks, despite evidence suggesting that longer CM interventions result in better post-treatment outcomes. Therefore, the overall objective of our program of research is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention. In a pilot trial, we developed a telehealth-based PEth CM intervention where participants used a medical device, the TASSO-M20 to self-collect blood for PEth testing under the observation of research staff over Zoom. This intervention used a two-phase approach where the frequency of PEth testing and reinforcement was decreased from once a week, to as infrequently as every four weeks once participants achieved a PEth level consistent with two to four weeks of abstinence (< 20 ng/mL). Seventy-one percent of CM participants achieved >4 weeks of abstinence versus 21% of the treatment as usual (TAU) group, and 43% of CM participants achieved >24 weeks of abstinence compared to 0% of the TAU group (p < 0.05). Based on these promising results, we now propose to test our telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). We will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth ³ 200 ng/mL), and alcohol-related harms (e.g., smoking, drug use). We will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. The primary barrier to the dissemination of our model is the cost of PEth testing and CM reinforcers. We will conduct an economic analysis to place these costs in the context of downstream CM-associated cost- offsets and improvements in personal and public health. If our model increases alcohol abstinence and is cost- effective it could reach millions of Americans with AUD that cannot or do not seek in-person care.