Self-help Smokeless Tobacco Cessation for Young Users

描述(由申请人提供)：该第二阶段项目的目的是进一步开发和评估针对青少年和年轻成人无烟烟草(ST)使用者的计算机化自助戒烟干预的效果。该计划利用一台小型手持计算机，按计划逐步减少低血压或咀嚼的频率和持续时间，直到实现停止为止。在第一阶段，对30名年龄在16岁至23岁之间的无烟烟草使用者进行了该计划的可行性测试，他们在六周的时间里使用了该计划。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酒，并通过唾液可替宁分析证实达到了7天的戒断点。那些未能戒烟的人减少了53%的ST使用量。受试者对该计划给予了肯定的评价，但指出，在用于研究的原型研究单位交付程序很难携带，也很难定期使用。对于第二阶段，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，该设备大小约为钥匙链FOB，便于携带。此外，将设计一个鼻烟壶盖子支架，允许用户用他们的鼻烟壶携带设备，从而进一步提高易用性和合规性。然后，将在350名青少年和年轻成年ST用户的多地点试验中对第二阶段计划进行评估。受试者将被随机分配到接受手动自助程序(足够的鼻烟)或用于勺子和咀嚼的QuitKey(QuitKey DC)。ST的使用和相关变量将在基线以及治疗开始后8周和26周进行评估。这项研究的结果将提供这两种最小接触、自助治疗对青少年和年轻成年ST使用者的相对疗效的数据，并将确定建议的产品对于几乎没有有效戒烟选择的年轻ST使用者是否是一种可行的戒烟选择。通过对ST使用者的药物使用轨迹进行早期干预，可以在长期身体依赖和对健康产生负面影响之前实现戒烟。

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.