Self-help Smokeless Tobacco Cessation for Young Users

描述（由申请人提供）：这个第二阶段项目的目的是进一步开发和评估计算机自助戒烟干预对青少年和年轻人无烟烟草（ST）使用者的效果。该程序利用一个小型手持计算机来提供一个预定的逐渐减少的频率和持续时间的下降或咀嚼，直到停止。在第一阶段，对30名年龄在16至23岁之间的无烟烟草使用者进行了为期六周的可行性测试。在治疗结束时，20%的治疗意向样本和33%的治疗完成者持续戒断，并通过唾液可替宁分析证实达到7天点流行戒断。戒烟失败的人减少了53%的ST使用。研究对象对该程序的评价是积极的，但他们指出，在用于研究的原型研究单元上交付该程序很难携带，也很难定期使用。在第二阶段，将根据第一阶段的反馈进一步完善程序算法，并将程序移植到新开发的专用设备（QuitKey）上，该设备约为钥匙链FOB大小，便于携带。此外，还将设计一种鼻烟罐盖架，使用户可以将设备与鼻烟罐一起携带，从而进一步提高使用的便利性和合规性。II期项目将在350名青少年和年轻成人ST使用者的多地点试验中进行评估。受试者将被随机分配，接受手动自助计划（足够的鼻烟）或为蘸水和咀嚼者提供的QuitKey （QuitKey DC）。ST的使用和相关变量将在基线和治疗开始后8周和26周进行评估。研究结果将提供关于这两种最小接触的相对功效的数据，即青少年和年轻成人性侵使用者的自助治疗，并将确定拟议的产品是否是年轻性侵使用者的可行戒烟选择，因为他们几乎没有有效的戒烟选择。通过早期干预ST使用者的药物使用轨迹，可以在长期身体依赖和负面健康影响发展之前实现戒烟。

DESCRIPTION (provided by applicant): The purpose of this Phase II project is to further develop and evaluate the efficacy of a computerized self-help cessation intervention for adolescent and young adult smokeless tobacco (ST) users. The program utilizes a small handheld computer to deliver a scheduled gradual reduction of the frequency and duration of dips or chews until cessation is achieved. In Phase I, the feasibility of the program was tested with 30 smokeless tobacco users age 16 to 23 who utilized the program over a six week period. At the end of treatment, 20% of the intent to treat sample and 33% of the treatment completers were continuously abstinent and met 7-day point prevalence abstinence confirmed by saliva cotinine analysis. Those who failed to quit reduced their ST use by 53%. Subjects rated the program positively, but noted that delivery of the program on the prototyping research units used for the study were difficult to carry and hard to use regularly. For Phase II, the program algorithms will be further refined based on Phase I feedback and the program will be ported to a newly developed special purpose device (QuitKey) which is about the size of a keychain FOB and easy to carry. In addition, a snuff can lid holder will be engineered to allow the user to carry the device with their snuff can, thereby further improving ease of use and compliance. The Phase II program will then be evaluated in a multi-site trial of 350 adolescent and young adult ST users. Subjects will be randomly assigned to receive either a manual self-help program (Enough Snuff) or the QuitKey for Dippers and Chewers (QuitKey DC). ST use and related variables will be assessed at baseline and at 8 and 26 weeks post treatment initiation. The results of the study will provide data on the relative efficacy of these two minimal contacts, self-help treatments for adolescent and young adult ST users, and will determine if the proposed product is a viable cessation option for young ST users for whom few effective cessation options are available. By intervening early in the drug use trajectory of ST users, cessation can be achieved before long-term physical dependence and negative health effects develop.