Examining the Role of Cooling Agents in Oral Nicotine Pouches
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sensory ratings
研究概览
简要总结
This clinical trial studies how the flavors and synthetic coolant properties in oral nicotine pouches (ONPs) compare to one another and how these characteristics are perceived by users. ONPs are placed between the gum and lip, and the nicotine is absorbed in the mouth. They have a strong potential for harm reduction if smokers can switch to using them, and they are growing in popularity. One factor that could be contributing to the increase in popularity is the wide range of flavors, including mint or menthol. With recent flavor restriction policies that have gone into effect in certain areas of the United States, ONPs are now including synthetic cooling agents (WS-3) in place of the flavors. They provide a cooling sensation, but do not have a characterizing flavor, like mint or menthol, allowing them to be sold where flavor restriction policies are in place. Learning more about the flavors and cooling properties in ONPs and user preferences may help researchers guide future ONP regulation and understand how these characteristics may be used as a potential harm reduction or quit smoking tool.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the individual and joint effects of menthol flavors and WS-3 on appeal of ONPs.
II. Test the individual and joint effects of menthol flavors and WS-3 on self-reported relief of withdrawal and craving symptoms associated with use of ONPs.
II. Compare demand for ONPs that vary according to menthol flavors and WS-3.
OUTLINE: Participants are randomized to sample 4 ONPs in a 1 visit, 4-session, randomized cross-over study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
In a double-blind, randomized crossover design, N=30 adult daily cigarette smokers will sample 4 ONPs with varying flavor and synthetic coolant properties. Participants are blinded to their study product(s) and will not be unblinded.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 years or older
- •Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits
- •Ability to read and speak English
- •Has smoked >= 100 cigarettes
- •Smokes >= 5 cigarettes/day for past year
排除标准
- •Use other tobacco products (including ONPs) more than 10 days per month
- •Unstable or significant psychiatric conditions (past and stable conditions allowed)
- •Pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each visit)
- •History of cardiac event or distress within the past 3 months
- •Currently attempting to quit all tobacco use
研究组 & 干预措施
Chill (WS-3 only)
Participants receive Chill-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Carbon Monoxide Measurement (Procedure)
Chill (WS-3 only)
Participants receive Chill-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Nicotine Oral Pouch (Drug)
Chill (WS-3 only)
Participants receive Chill-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Questionnaire Administration (Other)
Menthol (menthol only)
Participants receive Menthol-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Carbon Monoxide Measurement (Procedure)
Menthol (menthol only)
Participants receive Menthol-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Nicotine Oral Pouch (Drug)
Menthol (menthol only)
Participants receive Menthol-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Questionnaire Administration (Other)
Peppermint (menthol+WS-3)
Participants receive Peppermint-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Carbon Monoxide Measurement (Procedure)
Peppermint (menthol+WS-3)
Participants receive Peppermint-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Nicotine Oral Pouch (Drug)
Peppermint (menthol+WS-3)
Participants receive Peppermint-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Questionnaire Administration (Other)
Smooth (no menthol or WS-3)
Participants receive Smooth-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Carbon Monoxide Measurement (Procedure)
Smooth (no menthol or WS-3)
Participants receive Smooth-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Nicotine Oral Pouch (Drug)
Smooth (no menthol or WS-3)
Participants receive Smooth-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
干预措施: Questionnaire Administration (Other)
Usual brand cigarette visit
Participants smoke their usual brand cigarette over 5 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and a tobacco purchase task.
干预措施: Carbon Monoxide Measurement (Procedure)
Usual brand cigarette visit
Participants smoke their usual brand cigarette over 5 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and a tobacco purchase task.
干预措施: Questionnaire Administration (Other)
Usual brand cigarette visit
Participants smoke their usual brand cigarette over 5 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and a tobacco purchase task.
干预措施: Smoke usual brand cigarette (Drug)
结局指标
主要结局
Sensory ratings
时间窗: 5, 15, and 30 minutes after initial product use. To be completed on the day of the study visit. The visit will last approximately 2.5 hours
Sensory ratings will be evaluated with the general Labeled Magnitude Scale (gLMS), a 5-item self-report measure completed following ONP use. Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.
Withdrawal and Craving
时间窗: 0, 5, 15, and 30 minutes after initial product use.To be completed on the day of the study visit. The visit will last approximately 2.5 hours
Nicotine withdrawal and craving will be assessed using the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS is the sum of 8 items rated on a 5-point scale from 0 (none) to 4 (severe) with scores ranging from 0 to 32; MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate greater withdrawal/craving.
Appeal ratings
时间窗: 5, 15, and 30 minutes after initial product use. To be completed during the cigarette visit.
The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective appeal. The 11-item mCEQ includes five subscales: Satisfaction, Psychological Reward, Aversion, Enjoyment, and Craving Reduction. Individual items are rated from 1 (not at all) to 7 (extremely likely) and are averaged to create each subscale also ranging from 1 to 7. Higher values indicate greater levels of satisfaction, reward, aversion, enjoyment, and craving reduction.
Demand indices
时间窗: At the end of each ONP sampling session. To be completed on the day of the study visit. The visit will last approximately 2.5 hours
After product use, participants will complete a purchase task to assess demand indices including demand elasticity.
次要结局
未报告次要终点
研究者
Brittney Keller-Hamilton
Principal Investigator
Ohio State University Comprehensive Cancer Center