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临床试验/NCT06617520
NCT06617520已完成不适用

Attitudes and Smoking Perceptions in the Real Environment

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2024年4月15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
29
试验地点
2
主要终点
Number of cigarillos smoked

研究概览

简要总结

This study will measure appeal and reinforcement for different flavored little cigars/cigarillos (LCCs) in young adults in the laboratory and at-home, via ecological momentary assessment (daily smart-phone surveys)

详细描述

Participants will attend 4 laboratory sessions that differ by cigarillo smoked: own brand and a then commercially available study cigarillo (Garcia y Vega game cigarillo) in tobacco flavor, concept flavor, and characterizing flavor. Consistent with our work and other's published work8-10, a baseline (BL) period will measure appeal to smoking one's usual brand cigarillo in their home environment for 7 days and then once in the laboratory (>12-hour abstinence), at the end of the 7 days. Participants will then undergo 3 experimental conditions (counterbalanced, within-subjects): (1) 7 days smoking a concept flavored study cigarillo; (2) 7 days smoking a characterizing flavored study cigarillo; and (3) 7 days smoking a tobacco flavored study cigarillo. Participants will be instructed to switch their usual brand cigarillo for the assigned study cigarillo for each 7-day period. Other tobacco use will be allowed during that time without specific instruction to model real-world behavior. On the last day of each 7-day period of "take home" use, abstinent participants (>12 hours) will smoke the assigned study cigarillo in the lab ad libitum, where subjective effects (e.g., satisfaction, craving reduction, psychological reward, throat hit), smoke exposure (CO boost), and behavior (e.g., number of puffs) will be assessed During each 7-day period of exposure, participants will complete assessments of cigarillo and other tobacco use and subjective effects to cigarillo use via once daily EMA.

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
None

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages18 to 34
  • Smoke little cigars/cigarillos (LCCs) "some days" or "everyday"
  • Ability to read English at an 8th grade level or higher
  • No immediate plans to quit using tobacco

排除标准

  • Current use of nicotine replacement therapy (NRT)
  • Pregnant, planning to become pregnant, or currently breastfeeding
  • Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion Inability to abstain from nicotine/tobacco products for at least 12 hours prior to each of two study sessions
  • Report using the study cigarillo brand as their preferred brand (as this will likely unduly influence their perceptions)
  • Unwillingness to use "untipped" (e.g., plastic or wood tip) little cigars/cigarillos.

结局指标

主要结局

Number of cigarillos smoked

时间窗: Daily smartphone surveys, up to 3 weeks after the baseline

The number of cigarillos smoked during each 7-day take-home period

Subjective response to smoking

时间窗: Laboratory visits, up to 3 weeks after the baseline

average ratings of psychological reward following smoking from Modified Cigarette Evaluation Scale. Higher scores indicate higher reward. Score responses range from 1 to 7

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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