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.

项目概要 尽管人们越来越多地使用电子烟（EC），但人们对性别知之甚少 当前可燃卷烟 (CC) 与电子烟使用相关的潜在风险和益处的差异 吸烟者。为了帮助解决此类问题，NIDA 委托开发了一个标准研究 E- 香烟 (SREC) 和 2 年 FOA (PAR-18-220) 鼓励其评估。许多证据表明 男性和女性 CC 吸烟者在尼古丁消耗量、强化程度、戒断严重程度和戒断程度方面存在差异。 戒烟率。然而，目前尚不清楚这些因素是否因 EC 的结果而存在性别差异。 使用。根据本 FOA，本提案的目标是描述以下情况下潜在的性别差异： 在产品使用、产品可接受性、强化和改善方面从 CC 转向尼古丁和安慰剂 SREC 成年每日 CC 吸烟者的尼古丁依赖症状。参与者 (n=140) 包括 70 名男性和 70 名 目前对戒烟不感兴趣但有兴趣每天吸烟的成年女性 尝试 EC。参与者将在第 1 阶段（基线；第 1-2 周）吸食其常用品牌 (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- 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 转用尼古丁与安慰剂 SREC 对产品使用的影响， 成年每日 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 吸烟者转用尼古丁与安慰剂 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；和 (3) 其中 因素调节或介导男性从 CC 转向尼古丁和安慰剂 SREC 的影响 和女性 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 众所周知，男性和女性对尼古丁产品的反应不同，并为 NIDA 提供 有关 CC 用户转向 SREC 的能力方面潜在性别差异的信息， SREC 与 CC 的比较以及 SREC 和 CC 的双重/多重使用的影响。这个提议很有创新性 因为它将描述男性和女性之间从 CC 转向 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依据 有关标准化研究电子烟是否被男性和女性使用和接受的信息 女性 CC 吸烟者，这表明它是否可以作为未来电子烟研究的良好模型。