An Administrative Supplement to Increase the Recruitment Rates of R01 DA047301 a Pivotal Trial of a Novel Digital Therapeutic for Smoking Cessation in Psychiatric Populations

项目摘要/摘要 这份支持现有NIH赠款和合作协议的行政补编(PA-20-272)将 提高R01 DA047301的招募能力，以成功达到FDA关键试验的目标。 在患有严重精神疾病的个人中，烟草使用率仍然高得令人震惊，例如 精神分裂症、躁郁症和复发性抑郁障碍。吸烟是第一位的 可预防的死亡原因，使患有严重精神疾病的成年人的寿命缩短了 25年，并导致3170亿美元的医疗支出以及间接收入损失和残疾 福利。为个人提供更广泛的戒烟干预的新的有效模式 严重精神疾病患者是非常需要的，并被列为国家卫生研究院的优先事项。数字治疗(DTX)是 一种很有希望的方法，为患有严重精神疾病的人提供戒烟治疗。尽管 大量DTX可用于严重精神疾病患者，我们的可行性研究有 表明使用DTX给这一群体带来了艰巨的挑战。基于这项工作，我们 开发了一款以用户为中心的戒烟DTX，专为有以下需求的个人量身定做 严重的精神疾病。DTX的主要活性成分是一种新的行为疗法，它已经显示出 承诺作为戒烟干预--接受与承诺疗法。DTX提供 尼古丁替代疗法的使用教育和来自美国临床实践的建议 确保与最佳临床实践保持一致的指导方针。在一项试点随机对照试验中(R00 DA037276)，将学习戒烟与NCI的QuitGuide进行比较，我们证明：(1)高招聘和 留存率，(2)高水平的用户参与度，(3)进行 大型多点随机对照试验，以及(4)有希望的戒烟结果。虽然这一发展 工作提供了学习戒烟的可用性、可行性和大规模的初步效果的初步证据 需要随机对照试验来测试其在具有代表性的重症患者样本中的疗效。 精神疾病。因此，拟议的关键试验将：(1)采用随机平行臂设计，以 比较学习戒烟和简单建议的效果，(2)使用严格的方法来评估机械性 这种DTX的流程，以及(3)检查学习戒烟的成本效益与以下简短建议的比较 这群病人。这项关键的试验解决了一个严重的问题--吸烟率高的人 严重的精神疾病--并建议测试一种容易获得的戒烟方法的效果 使用具有高人口水平覆盖潜力的技术进行干预。

PROJECT SUMMARY/ABSTRACT This Administrative Supplement to Support Existing NIH Grants and Cooperative Agreements (PA-20-272) will boost the recruitment capacity of R01 DA047301 to successfully meet the aims of an FDA pivotal trial. Tobacco use remains at alarming high rates amongst individuals with serious mental illness, such as schizophrenia spectrum, bipolar, and recurring depressive disorders. Smoking tobacco is the number one preventable cause of death in this population, shortening the lifespan of adults with serious mental illness by 25 years and contributing to $317 billion in healthcare expenditures and indirect loss of earnings and disability benefits. Novel and effective models to deliver wider-reaching smoking cessation interventions to individuals with serious mental illness are highly needed and indicated as a priority for NIH. Digital Therapeutics (DTx) are a promising method to deliver smoking cessation treatments to people with serious mental illness. Despite numerous DTx available to use for people with serious mental illness, our feasibility research has demonstrated that using DTx presents daunting challenges for this population. Based on this work, we developed Learn to Quit, a user-centered smoking cessation DTx tailored to the needs of individuals with serious mental illness. The DTx’s main active ingredient is a novel behavioral treatment that has shown promise as a smoking cessation intervention -- Acceptance and Commitment Therapy. The DTx provides education about the use of nicotine replacement therapy and recommendations from US Clinical Practice Guidelines to ensure alignment with best clinical practices. In a pilot randomized controlled trial (R00 DA037276), comparing Learn to Quit versus NCI’s QuitGuide, we demonstrated: (1) high recruitment and retention rates, (2) high levels of user engagement with Learn to Quit, (3) an effective method to conduct a large multi-site randomized controlled trial, and (4) promising cessation outcomes. While this developmental work provides initial evidence of Learn to Quit’s usability, feasibility, and preliminary efficacy, a large scale randomized controlled trial is needed to test its efficacy in a representative sample of patients with serious mental illness. Therefore, the proposed pivotal trial will: (1) employ a randomized parallel arm design to compare the efficacy of Learn to Quit vs. Brief Advice, (2) use rigorous methods to evaluate mechanistic processes of this DTx, and (3) examine the cost-effectiveness of Learn to Quit compared to a Brief Advice for this patient population. This pivotal trial addresses a serious problem -- high smoking rates among people with serious mental illness -- and proposes to test the efficacy of an easily-accessible smoking cessation intervention using technology with the potential for high population-level reach.