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

提高 R01 DA047301 招募率的行政补充精神病人群戒烟新型数字疗法的关键试验

基本信息

批准号：
10818811
负责人：
Roger Vilardaga
金额：
$ 7.99万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-03-15 至 2024-12-31
项目状态：
已结题

项目摘要

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.

项目摘要/摘要这种行政补充以支持现有的NIH赠款和合作协议（PA-20-272）将提高R01 DA047301的招聘能力成功实现了FDA关键试验的目标。烟草的使用仍然令人震惊，患有严重精神疾病的人，例如精神分裂症谱，双极和反复出现的抑郁症。吸烟是第一可预防该人群的死亡原因，通过 25年，贡献了3170亿美元的医疗支出和间接损失收入和残疾好处。新颖有效的模型，向个人提供广泛的戒烟干预措施严重的精神疾病非常需要，并表示为NIH的优先事项。数字治疗学（DTX）是一种有前途的方法，是为严重精神疾病的人提供戒烟治疗。尽管许多DTX可用于严重精神疾病的人，我们的可行性研究已有证明，使用DTX对该人群提出了艰巨的挑战。基于这项工作，我们开发学习退出，以用户为中心的戒烟DTX根据个人的需求量身定制严重的精神疾病。 DTX的主要活性成分是一种新型的行为治疗，已显示承诺作为戒烟干预 - 接受和承诺疗法。 DTX提供关于使用尼古丁替代疗法和美国临床实践建议的教育确保与最佳临床实践保持一致的指南。在一项飞行员随机对照试验中（R00 DA037276），比较学习退出与NCI的戒烟指导，我们证明了：（1）高招聘和保留率，（2）高水平的用户参与度学习退出，（3）一种有效的方法大型多站点随机对照试验和（4）承诺停止结果。而这种发展工作提供了学会戒除的可用性，可行性和初步效率的初始证据需要随机对照试验来测试其在认真患者的代表性样本中的有效样本精神疾病。因此，拟议的关键试验将：（1）员工一个随机平行臂设计到比较学习退出与简短建议的效率，（2）使用严格的方法评估机械此DTX的过程以及（3）检查学会退出的成本效益，与简短的建议相比这个患者人数。这项关键试验解决了一个严重的问题 - 患有严重的精神疾病 - 以及测试易于访问的戒烟效率的建议使用技术的干预措施有可能获得高度人口水平的范围。