Gender differences in Standard Research E-Cigarette (SREC) products use, acceptability, reinforcement, and nicotine dependence symptoms

项目摘要 尽管电子烟（EC）在人群中的使用越来越多，但对性别知之甚少。 与当前可燃香烟（CC）中使用电子烟相关的潜在风险和益处的差异 吸烟者。为了帮助解决这样的问题，NIDA委托开发了一个标准研究电子版， 香烟（SREC）和2年FOA（PAR-18-220），以鼓励其评价。许多证据表明， 男性和女性CC吸烟者在尼古丁消耗、强化、戒断严重程度和 退出率。然而，这是很大程度上不知道是否有性别差异，这些因素的结果，EC 使用.根据该FOA，本提案的目标是描述潜在的性别差异， 从关于产品使用、产品可接受性、强化和 成人每日CC吸烟者的尼古丁依赖症状。受试者（n=140）为70名男性和70名 目前对戒烟不感兴趣，但有兴趣 尝试EC。受试者将在第1阶段（基线;第1-2周）吸烟其常用品牌（UB）CC产品 并将被指示使用SREC（尼古丁[15 mg/mL; SREC-NIC]或安慰剂[0 mg/mL; SREC-NIC]）。 PLA]），在第2阶段（第3-4周）和第3阶段（第5-6周），每当他们有吸烟的冲动时。我们的目标将 表征：（1）从CC转换为尼古丁与安慰剂SREC对产品使用的影响， 成人每日CC吸烟者的产品可接受性、强化和尼古丁依赖症状;（2） 男性和女性CC吸烟者在转换为尼古丁与安慰剂SREC时的差异， 关于产品使用、产品可接受性、强化和尼古丁依赖症状的CC;以及（3） 因素缓和或介导男性从CC转换为尼古丁和安慰剂SREC的影响 女性CC吸烟者该项目意义重大，因为它将单独检查SREC使用的影响 对于男性和女性来说，众所周知，他们对尼古丁产品的反应不同，并为NIDA提供 关于CC用户转换到SREC的能力方面的潜在性别差异的信息， SREC与CC相比的效果，以及SREC和CC的双重/多重使用。这一建议具有创新性 因为它将描述男性和女性之间从CC转换到SREC的潜在差异， 使用对照临床试验设计的女性。这项研究的积极影响将是提供科学的 关于标准化研究电子烟是否被男性使用和接受的信息， 女性CC吸烟者，这将表明它是否可以作为未来电子烟研究的一个很好的模型。

PROJECT SUMMARY Despite increasing use of electronic cigarettes (ECs) in the population, little is known about gender differences in the potential risks and benefits associated with e-cig use in current combustible cigarette (CC) smokers. To help address questions like this, NIDA commissioned the development of a Standard Research E- Cigarette (SREC) and a 2-year FOA (PAR-18-220) to encourage its evaluation. Much evidence suggests that male and female CC smokers differ in terms of nicotine consumption, reinforcement, withdrawal severity, and quit rate. However, it is largely unknown whether there are gender differences in these factors as result of EC use. Pursuant to this FOA, the objective of this proposal is to characterize potential gender differences when switching to nicotine and placebo SRECs from CCs on product use, product acceptability, reinforcement, and nicotine dependence symptoms among adult daily CC smokers. Participants (n=140) will be 70 male and 70 female adult daily CC smokers who are currently uninterested in quitting smoking but who are interested in trying ECs. Participants will smoke their usual brand (UB) CC products during Phase 1 (Baseline; weeks 1-2) and will be instructed to use the SREC (either nicotine [15 mg/mL; SREC-NIC] or placebo [0 mg/mL; SREC- PLA]), during Phases 2 (weeks 3-4) and 3 (weeks 5-6) whenever they have the urge to smoke. Our aims will be to characterize: (1) The effects of switching to nicotine vs. placebo SRECs from CCs on product use, product acceptability, reinforcement, and nicotine dependence symptoms among adult daily CC smokers; (2) the differences between male and female CC smokers when switching to nicotine vs. placebo SRECs from CCs on product use, product acceptability, reinforcement, and nicotine dependence symptoms; and (3) which factors moderate or mediate the effects of switching to nicotine and placebo SRECs from CCs among male and female CC smokers. This project is significant because it will examine the impact of SREC use separately for men and women, who are known to respond to nicotine products differently, and provide NIDA with information about potential gender differences in the ability of CC users to switch to SRECs, in the reinforcing effects of SRECs compared to CCs, and in dual/poly use of SRECs and CCs. This proposal is innovative because it will characterize the potential differences of switching to SRECs from CCs between men and women using a controlled clinical trial design. The positive impact of this study will be to provide scientific information on whether a standardized research e-cig is found to be used and accepted by both men and women CC smokers, which would indicate whether it could serve as a good model of future e-cig research.