Flavors and E-cigarette Effects in Adolescent Smokers- STUDY 1
2020年4月30日 更新者：Yale University
This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers.
The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.
研究概览
研究类型
介入性
注册 (实际的)
59
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Connecticut
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New Haven、Connecticut、美国、06519
- CMHC
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 20年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Ages 18-20 years
- Able to read and write
- Cigarette smoker
- Use of e-cigarettes in the past 30 days
Exclusion Criteria:
- Seeking smoking cessation treatment
- Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
- Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
- Current or past history of psychosis or other psychiatric diagnosis such as major depression
- Any significant current medical condition
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Tobacco Flavor
In this arm, subjects will receive tobacco flavor- without nicotine (placebo).
Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
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A low dose of menthol will be added to the tobacco flavor.
A high dose of menthol will be added to the tobacco flavor.
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有源比较器：Low Dose Nicotine
In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor.
Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
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A low dose of menthol will be added to the tobacco flavor.
A high dose of menthol will be added to the tobacco flavor.
Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
|
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有源比较器：High Dose Nicotine
In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor.
Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.
|
A low dose of menthol will be added to the tobacco flavor.
A high dose of menthol will be added to the tobacco flavor.
Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Liking/effect score of the e-cigarette
大体时间：Every 30 min for 120 min during lab session
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The Drug Effects Questionnaire (Soria et al) will be used to ask about participants' liking/effect of the e-cigarettes smoked during the 4 bouts of e-cigarette puffing during the lab session to determine which menthol dose is most preferred.
A linear mixed-effects regression model wil be used with nicotine group (none, low, high) as between-subject factor, and menthol dose (none, low dose, high dose) as within-subject factor.
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Every 30 min for 120 min during lab session
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maximum value of money at which the e-cigarette is chosen over money
大体时间：Every 30 min for 120 min during lab session
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E-cigarette value will be determined using the Multiple Choice Procedure (Griffiths et al, 1993) to determine the reinforcing value of the e-cigarette.
The MCP involves sampling the e-cigarette and then making a discrete choice between the e-cigarette or a series of monetary values.
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Every 30 min for 120 min during lab session
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Change scores from baseline in Nicotine Withdrawal
大体时间：Every 30 min for 120 min during lab session
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The Minnesota Nicotine Withdrawal Scale (Hughes et al,1986) will be used to assess the magnitude of change in nicotine withdrawal symptoms during the lab session
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Every 30 min for 120 min during lab session
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Change scores from baseline in Tobacco Craving
大体时间：Every 30 min for 120 min during lab session
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The Brief Questionnaire on Smoking Urges (Tiffany & Drobes,1991) will be used to assess the magnitude of change in tobacco craving during the lab session
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Every 30 min for 120 min during lab session
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Dana Cavallo, PhD、Yale University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年10月23日
初级完成 (实际的)
2016年7月18日
研究完成 (实际的)
2017年6月12日
研究注册日期
首次提交
2014年6月24日
首先提交符合 QC 标准的
2014年6月27日
首次发布 (估计)
2014年7月1日
研究记录更新
最后更新发布 (实际的)
2020年5月4日
上次提交的符合 QC 标准的更新
2020年4月30日
最后验证
2020年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.