Evaluation of the Electronic Cigarette Withdrawal Syndrome: Mechanistic Targets for Intervention
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Hughes-Hatsukami Withdrawal Scale
研究概览
简要总结
The goal of this project is to rigorously evaluate the nature of e-cigarette withdrawal in exclusive e-cigarette users during a monitored abstinence period and the role of nicotine in the expression of this withdrawal syndrome.
详细描述
This project will use a rigorous residential laboratory design to evaluate e-cigarette withdrawal expression and experimentally determine the role of nicotine in this syndrome. Healthy adults who exclusively use e-cigarettes will undergo monitored e-cigarette abstinence over seven days (1 week) in a residential unit. The investigators will evaluate the contribution of nicotine to withdrawal expression by assigning participants to one of three conditions: active nicotine patch, placebo patch control, or no patch to control for expectancies. Standardized behavioral and biological measures associated with withdrawal including patient report, cognitive task performance, and biometrics will be collected throughout to establish a rigorous timecourse of withdrawal and evaluate the contribution of nicotine to these symptoms.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-55 years old
- •good general health as reviewed by study medical team
- •vital signs in normal range as reviewed by study medical team
- •negative urine test for illicit drug use (excluding THC) and negative breath alcohol test
- •daily use of a nicotine-containing e-cigarette for at least 6 months
- •no regular use of other tobacco products (e.g., smokeless products) for at least 6 months
- •urine cotinine >100ng/mL (i.e., recommended cutoff for confirming current nicotine use)
- •exhaled breath carbon monoxide (CO) <6ppm
- •Penn State E-cigarette Dependence (PSED) score >=4, indicating mild dependence or greater
- •have an interest in reducing e-cigarette use
排除标准
- •psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month
- •current use of over-the-counter (OTC) or prescription medications that may impact safety
- •use cannabis >2 times per week
- •history of or current significant medical condition that would impact participation or safety according to the study investigators and medical staff
- •current psychiatric condition or substance use disorder (aside from tobacco use disorder) that would impact participation or safety according to the study investigators and medical staff
- •enrollment in another trial
- •positive pregnancy test
- •currently using a nicotine/tobacco cessation product
- •seizure disorder or traumatic brain injury (TBI)
研究组 & 干预措施
Transdermal Nicotine Patch
Participants assigned to this condition will receive a blinded nicotine patch and will wear the patch on their upper arm, per the manufacturer's instructions.
干预措施: Transdermal Nicotine Patch (Drug)
Transdermal Placebo Patch
Participants assigned to this placebo nicotine patch condition will receive a blinded patch containing 0mg of nicotine, and will wear the patch on their upper arm, per the manufacturer's instructions.
干预措施: Placebo Nicotine Patch (Drug)
结局指标
主要结局
Change in Hughes-Hatsukami Withdrawal Scale
时间窗: Baseline, every 4 hours up to 16 hours
The Hughes-Hatsukami Withdrawal Scale consists of 13 items presented individually on a 100mm visual analog scale. Higher scores reflect higher withdrawal (worse outcome) \[range 0-32\]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Smoking urges as assessed by the Tiffany-Drobes Questionnaire of Smoking Urges (QSU) Brief
时间窗: Baseline, every 4 hours up to 16 hours
The Tiffany-Drobes QSU Brief consists of ten items, each presented on the screen as a phrase centered above seven boxes ranging from (strongly disagree) to (strongly agree). Higher scores reflect higher withdrawal (worse outcome) \[range 0-70\]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Positive and Negative Affect Schedule (PANAS)
时间窗: Baseline, every 4 hours up to 16 hours
The PANAS consists of 20 items presented individually on a five-point Likert scale. Higher scores reflect more positive affect and negative affect \[range 0-50\]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Total sleep time
时间窗: Nightly up to seven days
Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.
Change in Memory as assessed by the N-Back
时间窗: Baseline, every 4 hours up to 16 hours
On the n-back, participants decide whether each stimulus in a sequence matches the one that appeared "n" items ago. Higher scores reflect more accuracy. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Conners' Continuous Performance Task (CPT)
时间窗: Baseline, every 4 hours up to 16 hours
On the CPT, participants respond to single letters appearing on their computer screen but are asked to refrain from responding to a specified letter(i.e., the letter X). Higher scores reflect more inattention. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Total time spent in Rapid eye movement (REM) sleep
时间窗: Nightly up to seven days
Total time sleeping in minutes in REM stage measured using actigraphy and unobtrusive EEG.
Wake after sleep onset (WASO)
时间窗: Nightly up to seven days
Total number of minutes that a person is awake after having initially fallen asleep measured using actigraphy and unobtrusive EEG.
次要结局
- Change in E-Cigarette Demand Intensity(Baseline, every 4 hours up to 16 hours)
- Return to Use(Day 14)
- Change in E-Cigarette Demand Elasticity(Baseline, every 4 hours up to 16 hours)