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

项目概要/摘要 2020年，2830万美国人经历了酒精使用障碍（AUD）;但只有25%的人 接受治疗。在大流行期间，60%的物质使用障碍患者报告说， 为他们的成瘾提供远程医疗服务。转向远程医疗提供了克服障碍的机会 影响亲自护理的访问和保留（例如，不便、耻辱）。在应急管理中 (CM)人们可以通过提交生物样本来验证禁欲情况，从而获得有形的禁欲证明。CM 是远程保健服务的理想选择，对远程保健模式的初步研究表明，酒精的使用有所减少。在 同时，这些模式也有局限性。他们需要佩戴透皮监测器或提交多个 每日呼吸样本。因此，这些方法是昂贵的、负担沉重的和污名化的，这限制了它们的应用。 可行性部分由于这些生物标志物的局限性，目前的CM模型是简短的，平均约12周， 尽管有证据表明，较长的CM干预导致更好的治疗后结果。因此，我们认为， 我们研究计划总体目标是利用磷脂酰乙醇（PEth），一种基于血液的生物标记物 它可以检测长达28天的酒精使用，以提供可行的基于远程医疗的26周CM干预。在 作为一项试点试验，我们开发了一种基于远程医疗的PEth CM干预，参与者使用医疗设备， TASSO-M20在研究人员通过Zoom观察下自行采血进行PEth检测。这 干预采用两阶段方法，其中PEth测试和强化的频率降低 从每周一次，到每四周一次，一旦参与者达到PEth水平， 戒断2 - 4周（< 20 ng/mL）。71%的CM参与者实现了>4周 与21%的常规治疗（TAU）组相比，43%的CM参与者达到了>24 与TAU组的0%相比，戒断时间为10周（p < 0.05）。基于这些令人鼓舞的结果，我们现在 建议在通过在线招募的AUD成年人样本（n=200）中测试我们基于远程医疗PEth的CM模型 通过将个人随机分配到6个月的平台，1）针对AUD的在线认知行为疗法 （CBT 4CBT）和远程医疗基于PEth的CM（CM条件）或2）CBT 4CBT和提交血液的自动化 样品（不需要禁欲）（对照条件）。我们将评估PEth定义的 戒酒和经常过量饮酒（PEth ≥ 200 ng/mL），以及酒精相关危害（例如，吸烟、吸毒 使用）。我们将通过评估12个月随访期间的结果来解决CM研究中的重要空白， 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 禁欲传播我们的模型的主要障碍是PEth测试和CM验证器的成本。 我们将进行经济分析，将这些成本置于下游CM相关成本的背景下， 抵消和改善个人和公共健康。如果我们的模型增加了酒精的节制并且是成本- 它可以帮助数百万无法或不寻求亲自护理的美国人。

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.