Varenicline OTC Trial on Efficacy and Safety

伐尼克兰非处方药疗效和安全性试验

• 批准号: 10174897
• 负责人: Raminta Daniulaityte
• 金额: $ 34.95万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-30 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10174897
• 关键词: Adherence; Adverse event; Affect; Bupropion; Cardiovascular system; Characteristics; Clinical Trials; Data; Dose; Drug Prescriptions; Ecological momentary assessment; Effectiveness; Environment; Ethnic Origin; FDA approved; Feeling suicidal; Goals; Health Personnel; Incidence; Inhalators; Interview; Label; Mediating; Nausea; Nicotine Inhaler; Nose; Outcome; Participant; Pattern; Perception; Persons; Pharmaceutical Preparations; Placebos; Probability; Research; Safety; Sleep; Sleep disturbances; Smoker; Smoking History; Smoking Status; Socioeconomic Status; Solid; Testing; Time; Tobacco Dependence; Treatment Efficacy; Treatment outcome; United States; Visit; Withdrawal; Work; experience; improved; medication compliance; nicotine replacement; placebo group; psychiatric symptom; response; side effect; smoking cessation; suicidal behavior; varenicline

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.

抽象的 七种药物已被批准用于治疗烟草成瘾 在美国，有五个是尼古丁替代品，两个是非尼古丁。三个 NRT 产品（即贴剂、口香糖、含片）可作为非处方药 (OTC) 购买 产品，因为临床试验表明它们是安全有效的，无需 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）进行过，证据明确，伐尼克兰具有最大的 帮助大多数吸烟者戒烟并导致不良事件的可能性 比目前的非处方 NRT 产品更糟糕。 鉴于这些数据，现在是时候探讨伐尼克兰是否安全且可靠了。 作为非处方药有效。另外，因为早期研究发现0.5mg 每天两次（b.i.d.）伐尼克兰与目前 FDA 批准的 1.0mg b.i.d. 一样有效 但由于恶心和睡眠障碍的发生率较低，因此评估是有价值的 在非处方药环境中，较低剂量是否和较高剂量一样有效。 因此，本研究的主要目标是测试伐尼克兰是否是固体 从处方药 (Rx) 转换为非处方药 (OTC) 的候选者，以及剂量是否低于 目前批准的药物在 OTC 环境中同样有效。去了解内在—— 人机机制解释非处方药伐尼克兰如何以及何时可以改善戒烟 结果，我们还建议通过（a）生态评估 OTC 伐尼克兰的经验 瞬时评估 (EMA) 和 (b) 对一部分参与者进行访谈。