Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in saliva nicotine concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 21 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Own Brand Cigarette Condition
干预措施: Tobacco product administration and assessment (Other)
Original-flavor Black&Mild cigar
干预措施: Tobacco product administration and assessment (Other)
Apple-flavor Black&Mild cigar
干预措施: Tobacco product administration and assessment (Other)
Cream-flavor Black&Mild cigar
干预措施: Tobacco product administration and assessment (Other)
Wine-flavor Black&Mild cigar
干预措施: Tobacco product administration and assessment (Other)
结局指标
主要结局
Change in saliva nicotine concentration
时间窗: 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).
Change in Tobacco Abstinence Symptoms and Drug Effects subjective abuse liability
时间窗: 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).
Change in breakpoint from two behavioral choice tasks (Cigarette Purchase Task, Multiple Choice Procedure)
时间窗: 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).
Change in Addiction Research Center Inventory subjective abuse liability
时间窗: 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).
Change in Direct Effects of Nicotine and Tobacco Scale subjective abuse liability
时间窗: 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).
次要结局
- Expired air carbon monoxide(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(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(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)(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)(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))