Varenicline OTC Trial on Efficacy and Safety

摘要 七种药物已被批准用于治疗烟草成瘾， 在美国，五种是尼古丁替代品，两种是非尼古丁。三 NRT产品（即贴剂、口香糖、锭剂）可作为非处方药（OTC）获得 产品，因为临床试验表明它们是安全有效的， 医疗保健提供者的参与。 经过多项研究，包括最大的戒烟试验之一， （“EAGLES”研究）进行，证据很明显，伐尼克兰有最大的 帮助大多数吸烟者戒烟的可能性，并导致不良事件， 比目前的OTC NRT产品更差。 鉴于这些数据，现在是时候探索伐尼克兰是否安全， 作为OTC药物有效。此外，由于早期的研究发现， 每日两次（b.i.d.）伐尼克兰与目前FDA批准的1.0 mg b.i.d 但恶心和睡眠障碍的发生率较低， 在OTC环境中，较低剂量是否与较高剂量一样有效。 因此，所提出的研究的主要目标是测试伐尼克兰是否是固体制剂。 从处方药（Rx）转换为OTC的候选人，以及剂量是否低于 目前批准的在OTC环境中同样有效。去了解内在- 解释OTC伐尼克兰如何以及何时可以改善戒烟的个人机制 结果，我们还建议通过（a）生态评估非处方伐尼克兰的经验 瞬时评估（EMA）和（B）参与者子集中的访谈。

Abstract Seven medications have been approved for the treatment of tobacco addiction in the United States, five that are nicotine replacement and two are non-nicotine. Three of the NRT products (i.e. patch, gum, lozenge) are available as over-the-counter (OTC) products because clinical trials have shown that they are safe and effective without healthcare provider involvement. After multiple studies, including one of the largest smoking cessation trials (`EAGLES' study) ever conducted, the evidence is clear that varenicline has the greatest probability of helping the most smokers quit and results in adverse events that are no worse than current OTC NRT products. Given these data, the time has come to explore whether varenicline is safe and effective as an OTC medication. In addition, because earlier research found that .5mg twice a day (b.i.d.) varenicline is as effective as the currently FDA-approved 1.0mg b.i.d but with lower incidence of nausea and sleep disturbance, there is value in assessing whether the lower dose will work as well as the higher dose in an OTC environment. Thus, the primary goal of the proposed research is to test whether varenicline is a solid candidate for switching from prescription (Rx) to OTC, and whether a dose lower than that currently approved is as effective in an OTC environment. To understand the within- person mechanisms explaining how and when OTC varenicline might improve cessation outcomes, we also propose to assess experience with OTC varenicline via (a) ecological momentary assessment (EMA) and (b) interviews in a subset of participants.