一项随机对照试验，评估基于远程医疗的应急管理干预是否能减少酒精使用障碍患者的酒精使用。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-01-15 DOI:10.1016/j.cct.2025.107807

Julianne D. Jett , Diana Tyutyunnyk , Rachael Beck , Katharine Palmer , Danielle Ryan , Jesus Sanchez , Douglas L. Weeks , Sterling M. McPherson , Naomi Chaytor , Brian Kiluk , Martin A. Javors , Brett C. Ginsburg , Sean Murphy , Nathalie Hill-Kapturczak , Michael G. McDonell

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引用次数: 0

摘要

背景：酒精生物标志物证实，应急管理（CM）是一种酒精使用障碍（AUD）的干预措施，可以加强戒酒。CM通常是短暂的（12-16 周），尽管有证据表明更长时间的干预具有更好的长期效果。大多数CM模型都是面对面的，这也可能成为治疗的障碍。需要对基于远程医疗的长时间CM模型进行研究。目的：在26周的干预和12个月的随访期间，确定利用磷脂酰乙醇（PEth）确认戒酒的远程医疗CM模型是否能有效减少酒精使用。我们将评估CM对酒精相关结果的影响，确定成瘾神经临床评估变量是否与随访结果相关，以及减少酒精使用相关的储蓄是否抵消干预成本。方法：通过在线广告招募居住在美国的成年AUD患者。研究程序将以虚拟方式进行。在入组时提交PEth阳性血液样本（≥20 ng/mL）的参与者将被随机分配到26 周，接受1)在线认知行为治疗（CBT4CBT），奖励不取决于PEth结果（对照组）或2)CBT4CBT，奖励最多1820美元（CM组）。peth阴性试验（初级）和peth定义的过量饮酒(≥200 ng/mL；二级)将被评估。还将调查干预结果和经济可行性的预测因素。讨论：如果这种远程医疗提供的基于peth的CM干预可以减少酒精使用并且具有成本效益，那么它可以用于为数百万没有接受当面护理的AUD患者提供有效的治疗。

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A randomized controlled trial to assess whether a telehealth-based contingency management intervention reduces alcohol use for individuals with alcohol use disorder

Background

Contingency management (CM) is an intervention for alcohol use disorder (AUD) that reinforces abstinence, as confirmed by alcohol biomarkers. CM is usually brief (12–16 weeks) despite evidence that longer interventions have better long-term outcomes. Most CM models are in-person which can also be a barrier for treatment. Studies of longer duration telehealth-based CM models are needed.

Aims

To determine if a telehealth-based CM model that utilizes phosphatidylethanol (PEth) to confirm abstinence is effective at reducing alcohol use during a 26-week intervention and 12-month follow-up. We will evaluate the impact of CM on alcohol-related outcomes, determine if Addiction Neuroclinical Assessment variables are associated with outcomes in follow-up, and whether savings related to decreased alcohol use offset intervention costs.

Methods

Adults with AUD residing in the United States will be recruited via online advertising. Research procedures will be conducted virtually. Participants who submit a PEth-positive blood sample (≥20 ng/mL) at enrollment will be randomized to 26 weeks of either 1) online cognitive behavior therapy (CBT4CBT) with rewards not contingent on PEth results (Control group) or 2) CBT4CBT with a maximum of $1,820 of rewards contingent on PEth results (CM group). Efficacy outcomes of PEth-negative tests (primary) and PEth-defined excessive drinking (≥200 ng/mL; secondary) will be assessed. Predictors of intervention outcomes and economic viability will also be investigated.

Discussion

If this telehealth-delivered PEth-based CM intervention reduces alcohol use and is cost-effective, it could be used to provide effective treatment to millions of individuals with AUD who do not receive in-person care.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.