Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 4
- 主要终点
- Total score on the Minnesota Nicotine Withdrawal Scale (MNWS)
研究概览
简要总结
The purpose of this study is to see whether adults who use e-cigarettes every day experience symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.
详细描述
Study Design: The investigators will recruit 120 individuals who are long-term daily and exclusive users of nicotine-containing e-cigarettes. Participants will be asked to use their own e-cigarette as usual during the first week of the study and to then stop their use of e-cigarettes for 6 days. The total study duration will be 14 days. Participants will be instructed to continue abstinence from other tobacco and nicotine products during the entire study. The investigators will use an escalating payment system with bonuses based on breath and urine samples to encourage compliance.
Every day during the study, participants will report e-cigarette and tobacco cigarette use and monitor symptoms of nicotine withdrawal via a phone call to an Interactive Voice Response system. Participants will attend 3 study visits each week to provide urine and breath samples to verify compliance, and to complete brief surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Able to read and understand verbal English fluently
- •US citizen or resident alien
- •Primarily uses e-cigarette product types of refillable tanks or modified devices
- •Uses nicotine-containing e-liquid
- •Has baseline urinary cotinine concentration of > 100 ng/ml
- •Has used e-cigarettes daily for the last 2 months
- •Has a home or cell phone
- •Agrees to abstain from tobacco, marijuana and other illegal drugs during study
排除标准
- •Smoked > 5 tobacco cigarettes in the last month
- •Used non-cigarette nicotine, tobacco or quit smoking products on >5 days in the past month
- •Use of cannabis (either marijuana or synthetic cannabis) > 5 times in the past month or positive test for cannabis use at screening
- •Current (last 6 months) Generalized Anxiety Disorder, Major Depressive Disorder, Attention Deficit Hyperactivity Disorder or moderate/severe Substance Abuse Disorder
- •Multiple legal, social health, work or school problems in the past month due to alcohol or drug use
- •Pregnant or breastfeeding
- •Previously a participant in the current study
- •Use of prescribed or non-prescribed psychoactive medication > 5 times in the past month
- •Expired carbon monoxide level > 8ppm
研究组 & 干预措施
Abstinence from e-cigarettes
Participants abstain from e-cigarettes and other nicotine/tobacco products for 6 days
干预措施: Abstinence from e-cigarettes (Behavioral)
E-cigarette use
Participants use e-cigarettes and continue to abstain from tobacco/nicotine products as they normally would.
结局指标
主要结局
Total score on the Minnesota Nicotine Withdrawal Scale (MNWS)
时间窗: 6 days
The investigators will compare the mean score across participants for the entire 6-day abstinence vs. use conditions.
次要结局
- Questionnaire of Smoking Urges- brief version(6 days)
- E-cigarette Purchase Task(6 days)
- Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS)(6 days)
- Questionnaire of E-cigarette Urges (brief)(6 days)
- Heart rate(6 days)
研究者
John Hughes
Faculty, Department of Psychiatry
University of Vermont