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临床试验/NCT03098004
NCT03098004已完成不适用

Effects of Electronic Cigarettes on Nicotine Withdrawal Among Smokers

University of Southern California2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
Positive Affect Negative Affect Schedule

研究概览

简要总结

This behavioral pharmacology laboratory experiment will assess whether sweet (vs. non-sweet) flavored e-cigarette solutions reduce tobacco withdrawal symptoms and motivation to smoke among 40 smokers interested in trying e-cigarettes (for the first time) following 16-hours of nicotine abstinence. The study's experimental design will provide evidence of the causal effects of e-cigarette flavorings on a putatively critical factor for determining whether smokers continue e-cigarette use after initial trial-the ability of a product to suppress withdrawal and motivation to smoke during periods of tobacco deprivation.

详细描述

Nicotine withdrawal symptoms (e.g., increased negative affect, decreased positive affect, cigarette craving) are a core component of cigarette dependence that emerge upon the absence of nicotine administration, maintaining cigarette smoking and inhibiting cessation efforts. The use of electronic cigarettes (e-cigarettes) has increased dramatically in recent years, with studies demonstrating that e-cigarettes can reduce nicotine withdrawal symptoms during acute cigarette abstinence. E-cigarettes with flavorings that simulate the sweet taste of fruit, candy and other sugary foods and beverages are widely available, commonly used and are frequently cited as a reason for the persistent use of e-cigarettes. During nicotine withdrawal, sweet flavors have been shown to reduce nicotine withdrawal symptoms. Additionally, a recent USC TCORS (Tobacco Center of Regulatory Science) administrative supplement study conducted at the University of Southern California (USC) Health, Emotion, and Addiction Laboratory (USC-HEAL) found that sweet-flavored solutions enhanced the appeal of e-cigarettes, independent of nicotine. However, the impact of e-cigarette flavorings on nicotine withdrawal symptoms is currently unknown. This behavioral pharmacology laboratory experiment will assess whether sweet (vs. non-sweet) flavored e-cigarette solutions reduce tobacco withdrawal symptoms and motivation to smoke among 40 smokers interested in trying e-cigarettes (for the first time) following 16-hours of nicotine abstinence. At each visit, participants will complete a standardized e-cigarette administration procedure, as developed in our prior work, in which flavor will be manipulated in a double-blind, cross-over, counterbalanced design. Following the e-cigarette administration, participants will complete: 1) self-report measures of nicotine withdrawal symptoms; 2) physiological measurements and 3) a behavioral task that measures participants' ability to resist the desire to resume smoking under conditions in which it is advantageous to remain abstinent (i.e., monetary payment for each successive 5-min increment in which smoking is delayed). The study's experimental design will provide evidence of the causal effects of e-cigarette flavorings on a putatively critical factor for determining whether smokers continue e-cigarette use after initial trial-the ability of a product to suppress withdrawal and motivation to smoke during periods of tobacco deprivation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21 years of age or older;
  • Daily cigarette smoking for at least the past two years;
  • Currently smoke > 10 cig/day;
  • Interest in trying e-cigarettes;
  • report primarily smoking non-mentholated cigarettes.

排除标准

  • Current use of medications that impact withdrawal or smoking (e.g., bupropion, varenicline, nicotine replacement, anti-depressants, anxiolytics);
  • Prior use of e-cigarettes (i.e., self-report > 10 puffs lifetime, use on more than two occasions, purchased own device);
  • breath carbon monoxide (CO) < 10 at intake;
  • pregnancy/breastfeeding; and
  • daily use of other tobacco products (e.g., hookah, cigars).

结局指标

主要结局

Positive Affect Negative Affect Schedule

时间窗: 4 hours

The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect.

The Minnesota Nicotine withdrawal Scale

时间窗: 4 hours

The Minnesota Nicotine withdrawal Scale (MNWS) measures 11 nicotine withdrawal symptoms on 6-point response scales.

次要结局

  • Wisconsin Smoking Withdrawal Scale(4 hours)
  • Questionnaire of Smoking Urges(4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Leventhal

Professor

University of Southern California

研究点 (2)

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