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

标准研究电子烟 (SREC) 产品使用、可接受性、强化和尼古丁依赖症状中的性别差异

• 批准号: 9788397
• 负责人: Jason D Robinson
• 金额: $ 75.98万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9788397
• 关键词: Address; Adult; Affect; Alkaloids; Anabasine; Benefits and Risks; Carbon Monoxide; Cellular Phone; Cigarette; Cigarette Smoker; Clinical Trials Design; Controlled Clinical Trials; Cotinine; Counseling; Dependence; Development; Electronic cigarette; Ethics; Ethnic Origin; Evaluation; Expectancy; Female; Future; Measures; Mediating; Menthol; Minor; Modeling; National Institute of Drug Abuse; Nicotine; Nicotine Dependence; Nicotine Withdrawal; Outcome; Outcome Measure; Participant; Phase; Placebos; Population; Psychological reinforcement; Public Health; Race; Research; Severities; Smoke; Smoking Behavior; Standardization; Symptoms; Text Messaging; Tobacco; Weight; Withdrawal; Withdrawal Symptom; Woman; cigarette smoking; cigarette user; combustible cigarette; craving; electronic cigarette use; gender difference; hormonal contraception; innovation; interest; male; men; nicotine replacement; nicotine use; preference; primary outcome; response; satisfaction; smoking cessation; standard care

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.

项目总结 尽管电子烟在人群中的使用越来越多，但人们对性别知之甚少 在当前的可燃香烟(CC)中使用电子烟的潜在风险和好处的差异 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E- 卷烟(SREC)和为期两年的FOA(PAR-18-220)，以鼓励其评估。许多证据表明， 男性和女性CC吸烟者在尼古丁摄入量、强化程度、戒断严重程度和 戒烟率。然而，在很大程度上还不清楚这些因素是否由于EC而存在性别差异 使用。根据这项《性别问题法》，本提案的目标是描述潜在的性别差异，如 从CCS转向尼古丁和安慰剂SRECs的产品使用、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。参与者(n=140)将是70名男性和70名 目前对戒烟不感兴趣但对戒烟感兴趣的成年女性每日CC吸烟者 试探一下ECS。参与者将在第1阶段(基线；第1-2周)吸用其常用品牌(UB)CC产品 并将被指示使用SREC(尼古丁[15毫克/毫升；SREC-NIC]或安慰剂[0毫克/毫升；SREC-NIC] 解放军])，在第2阶段(第3-4周)和第3阶段(第5-6周)，只要他们有吸烟的冲动。我们的目标将 将描述：(1)从CCS转向尼古丁与安慰剂SRECs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吸烟者改用尼古丁与安慰剂时的差异 关于产品使用、产品可接受性、强化和尼古丁依赖症状的CCS；以及(3) 在男性中，由CCS转向尼古丁和安慰剂SRECs的影响是温和或中介的 和女性CC吸烟者。这个项目意义重大，因为它将单独检查SREC的使用影响 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用户改用SREC的能力方面的潜在性别差异的信息，在加强中 与CCS相比，SRECs的影响，以及SRECs和CCS的双重/混合使用。这个建议很有新意 因为它将表征男性和男性之间从CCS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为 关于标准化研究电子CIG是否被发现被男性和 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式。