Varenicline OTC Trial on Efficacy and Safety

摘要 年，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。其中三个 NRT产品(如贴片、口香糖、含片)以非处方药(OTC)的形式提供 因为临床试验表明，在没有药物的情况下 医疗保健提供者的参与。 经过多项研究，包括最大规模的戒烟试验之一 (EAGLES研究)进行过的，证据很清楚，varenicline有最好的 帮助大多数吸烟者戒烟并导致不良事件的概率 比目前的OTC NRT产品更差。 考虑到这些数据，现在是时候探索伐伦克林是否安全和 作为非处方药有效。此外，因为早先的研究发现0.5毫克 一天两次(b.i.d.)Varenicline与目前FDA批准的1.0 mg b.i.d一样有效 但由于恶心和睡眠障碍的发生率较低，因此有价值的评估 在非处方药环境中，较低剂量是否与较高剂量一样有效。 因此，拟议研究的主要目标是测试伐伦克林是否为固体 从处方药(Rx)转换为非处方药的候选药物，以及剂量是否低于 目前批准的在场外交易环境中同样有效。为了理解内在的- 解释非处方药varenicline如何以及何时改善戒断的人机制 结果，我们还建议通过(A)生态学评估非处方药varenicline的使用经验 瞬时评估(EMA)和(B)对部分参与者的面谈。

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.