Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults
2019年4月22日 更新者：Virginia Commonwealth University
This study involves 25 current young adult combustible tobacco cigarette (CTC) smokers who will complete 5 Latin square ordered, within-subject, laboratory conditions that differ by the tobacco product smoked:
- own-brand CTC (positive control),
- original-flavored Black & Mild (B&M) cigar,
- apple-flavored B&M cigar,
- cream-flavored B&M cigar, and
- wine-flavored B&M cigar.
研究概览
研究类型
介入性
注册 (实际的)
25
阶段
- 不适用
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
-
-
Virginia
-
Richmond、Virginia、美国、23284
- VCU Behavioral Health Research Laboratory
-
-
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 21年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- To be included, participants must be healthy, as determined by self-report and heart rate/blood pressure (HR/BP) check, between the ages of 18-25, and willing to provide informed consent.
- They must agree to attend the lab and abstain from tobacco/nicotine as required, to use the designated products, and to follow the study protocol.
- Participants must also be regular CTC smokers (≥5 cigarettes/day for past 3 months) naïve to cigar products (smoked no more than 10 cigar products of any type in lifetime) who can provide a semi-quantitative urine cotinine result of ≥3 at screening (NicAlert test).
Exclusion Criteria:
- Individuals with a self-reported history of chronic diseases or psychiatric conditions will be excluded.
- Other exclusion criteria are: history of or active cardiovascular disease, current oral health problems or injuries, low/high BP, seizures, regular prescription medication use (other than vitamins or birth control), and past month use of cocaine, opioids, benzodiazepines, and methamphetamine (self-report).
- Individuals who report using marijuana or alcohol >20 days in the past 30 or interest in quitting CTC use within the next 30 days will also be excluded.
- Women will be excluded if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
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：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Own Brand Cigarette Condition
|
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
|
|
实验性的：Original-flavor Black&Mild cigar
|
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
|
|
实验性的：Apple-flavor Black&Mild cigar
|
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
|
|
实验性的：Cream-flavor Black&Mild cigar
|
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
|
|
实验性的：Wine-flavor Black&Mild cigar
|
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
|
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 |
|---|---|---|
|
Change in saliva nicotine concentration
大体时间：Saliva will be collected at baseline before the first product administration, at 10 min following each product administration, and 55 min following the first product administration (baseline for the second product administration).
|
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.
Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
|
Saliva will be collected at baseline before the first product administration, at 10 min following each product administration, and 55 min following the first product administration (baseline for the second product administration).
|
|
Change in breakpoint from two behavioral choice tasks (Cigarette Purchase Task, Multiple Choice Procedure)
大体时间：A behavioral choice task (cigarette purchase cask) will be completed at baseline before the first product administration, 5, 15, 30, and 45 min following each bout. 45 min after the second bout, the multiple choice procedure will be administered.
|
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.
Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
|
A behavioral choice task (cigarette purchase cask) will be completed at baseline before the first product administration, 5, 15, 30, and 45 min following each bout. 45 min after the second bout, the multiple choice procedure will be administered.
|
|
Change in Addiction Research Center Inventory subjective abuse liability
大体时间：Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
|
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.
Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
|
Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
|
|
Change in Direct Effects of Nicotine and Tobacco Scale subjective abuse liability
大体时间：Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
|
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.
Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
|
Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
|
|
Change in Tobacco Abstinence Symptoms and Drug Effects subjective abuse liability
大体时间：Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
|
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.
Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
|
Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Expired air carbon monoxide
大体时间：Expired air carbon monoxide measurement will occur at baseline before the first product administration, 15 minutes following each bout, 55 min following the first product administration (baseline for the second product administration).
|
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.
Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
|
Expired air carbon monoxide measurement will occur at baseline before the first product administration, 15 minutes following each bout, 55 min following the first product administration (baseline for the second product administration).
|
|
Heart rate
大体时间：Heart rate will be recorded at one second intervals from session onset (minute zero of session) through minute 155 of the session (end of session).
|
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
|
Heart rate will be recorded at one second intervals from session onset (minute zero of session) through minute 155 of the session (end of session).
|
|
Blood pressure
大体时间：Blood pressure will be recorded at 5 minute intervals from from session onset (minute zero of session) through minute 155 of the session (end of session).
|
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).
|
Blood pressure will be recorded at 5 minute intervals from from session onset (minute zero of session) through minute 155 of the session (end of session).
|
|
Puff Volume (ml)
大体时间：Puff Volume will be measured in seconds for each puff during product administration (10 puffs with a 30-second interpuff interval directed and monitored by staff)
|
The instrument senses flow-induced pressure drop across an orifice that is incorporated into the mouthpiece.
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.
Puff Volume and Puff Duration will be used to calculate measures of Puff Flow Rate (Puff Volume/Puff Duration) and Total Puff Volume (Puff Volume per puff x 10 puffs).
|
Puff Volume will be measured in seconds for each puff during product administration (10 puffs with a 30-second interpuff interval directed and monitored by staff)
|
|
Puff Duration (seconds)
大体时间：Puff Duration will be measured in seconds for each puff during product administration (10 puffs with a 30-second interpuff interval directed and monitored by staff)
|
The instrument senses flow-induced pressure drop across an orifice that is incorporated into the mouthpiece.
Each participant will attend 5 study sessions, each study session will include two bouts of product administration.
Puff Volume and Puff Duration will be used to calculate measures of Puff Flow Rate (Puff Volume/Puff Duration) and Total Puff Volume (Puff Volume per puff x 10 puffs).
|
Puff Duration will be measured in seconds for each puff during product administration (10 puffs with a 30-second interpuff interval directed and monitored by staff)
|
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
- 首席研究员：Andrew J Barnes, PhD、Virginia Commonwealth University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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)
2016年10月1日
初级完成 (实际的)
2019年4月12日
研究完成 (实际的)
2019年4月12日
研究注册日期
首次提交
2016年9月6日
首先提交符合 QC 标准的
2016年10月17日
首次发布 (估计)
2016年10月18日
研究记录更新
最后更新发布 (实际的)
2019年4月23日
上次提交的符合 QC 标准的更新
2019年4月22日
最后验证
2019年4月1日
更多信息
与本研究相关的术语
其他研究编号
- HM20007848
- R03DA043005 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Once appropriate, a completely de-identified data set will be created that obfuscates any variable that might potentially be used to identify an individual study participant.
In accordance with HIPAA definitions for public data sharing, the investigators will use standard acceptable processes that include removal of identifiers, translation of dates and ages to delta time values, assignment of random study identifiers, and any other methods acceptable at that time.
A data sharing agreement will be required for release of any data.
Individuals requesting a copy of study data will need to submit a detailed research plan that includes the purpose of the proposed research, the variables required, the duration of the analysis phase, IRB approval with FWA information, investigator training in human subjects, and other approvals specific to the individual datasets.
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.