Testing the Effect of ENDS Flavors on Neurotransmission
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Brain reward reactivity
研究概览
简要总结
The overarching goal of this translational proposal is to determine if neuroactive flavor chemicals can enhance the addiction potential of electronic nicotine delivery systems (ENDS) by altering brain function and behavior.
详细描述
For this randomized double-blind controlled trial, tobacco users will be randomized to use ENDS with an e-liquid containing a neuroactive flavor (hexyl acetate) vs. an inactive flavor (ethyl acetate) for ten days as a supplement to their typical tobacco use. Laboratory measures of ENDS reinforcement, subjective ENDS ratings, and brain reactivity to the flavor using functional magnetic resonance imaging (fMRI) will be collected at baseline and after ten days of ENDS use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 to 60 years old
- •Regular users of inhaled tobacco products (≥5 days out of the last 28)
- •Not planning to quit tobacco use within next month
- •Able to read and write in English
排除标准
- •Major neurological conditions or brain trauma
- •Current substance use impairing participation
- •Unstable or significant medical conditions (e.g., COPD, coronary heart disease)
- •Current use of smoking cessation medication (e.g., varenicline, patch)
- •Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
- •Known allergic reaction to ENDS liquids ingredients propylene glycol or vegetable glycerin
- •Unable to use study provided ENDS ad-libitum for at least 3 hours per day
- •Pregnant or breastfeeding as indicated by self-report or urine pregnancy screen
- •MRI-specific exclusion criteria:
- •MRI safety contraindications (e.g., metal implants, claustrophobia)
- •Major neurological conditions or brain trauma
研究组 & 干预措施
Hexyl Acetate
E-cigarette liquid containing hexyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
干预措施: Flavor (Other)
Ethyl Acetate
E-cigarette liquid containing ethyl acetate, ethyl maltol, propylene glycol, vegetable glycerin and methylbutyl acetate with nicotine salt.
干预措施: Flavor (Other)
结局指标
主要结局
Brain reward reactivity
时间窗: Pre to post-intervention (approximately 10 days)
Brain reward reactivity will be calculated as the percent change in average blood oxygen-level dependent (BOLD) signal in a pre-defined ventral tegmental area (VTA) region of interest during ENDS inhalation
Absolute reinforcement
时间窗: Pre to post-intervention (approximately 10 days)
Absolute reinforcement will be calculated as the change in the average number of puffs per day during a 10-day use period
Brain Reward Reactivity
时间窗: Pre to post-intervention (approximately 10 days)
Brain reward reactivity will be calculated as the difference in the percent of BOLD signal calculated by subtracting the absolute percentage at the post-scan from baseline in a pre-defined ventral tegmental area (VTA) region of interest during electronic nicotine delivery system (ENDS) inhalation.
Absolute Reinforcement
时间窗: Pre to post-intervention (approximately 10 days)
Absolute reinforcement will be calculated as the mean difference in puffs per day calculated as the average puffs per day during last four days minus the first four days of the 10-day use period.
次要结局
未报告次要终点
研究者
Andrea Hobkirk, PhD
Assistant Professor
Penn State University