Examining Appeal and Addiction Potential of Novel E-cigarette Constituents Among Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Liking: Score change in liking/wanting of each e-cigarette condition (5 conditions in total)
研究概览
简要总结
This study is an examination of the influence of cooling components of WS-3, WS-23, and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults.
详细描述
The investigators will examine the influence of cooling components of WS-3, WS-23 (synthetic coolants) and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults. Participants will rate the flavor intensity, coolness, sweetness, and irritation/harshness, bitterness experienced using validated rating scales. 66 adult participants (18+ years of age) who are current e-cigarette users will participate in 3 laboratory sessions. Participants will be randomized to receive one of the 3 menthol conditions (no-menthol, low menthol, high menthol) in Lab 1 and will receive the alternative conditions in randomized order in Lab 2 and Lab 3. During each lab session the menthol condition will be paired with three WS-3 concentrations: no WS-3, low (0.1%) WS-3, or high (2.0%) WS-3 and three WS-23 concentrations: low (0.1%) WS-23, high (2.0%) WS-23, or 4% WS-23 in randomized order. All e-cigarettes will contain nicotine salt at a nicotine concentration of ~59mg/ml and all participants will be exposed to eighteen conditions across 3 lab sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants will be given a nicotine containing e-cigarette that could have various levels of cooling flavoring. Participants will not be told the nicotine concentration of the product or the type or concentration of the added coolant or what order it is presented in. Investigator and research assistant (i.e. care provider) will know the doses of nicotine and coolant, but will not know what order coolants are presented to participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Able to read and write
- •Some current e-cigarette use
- •Urine cotinine ≥200ng/ml
- •Willing to abstain from tobacco/nicotine use 2 hours prior to sessions
排除标准
- •Current use of non-prescription substances besides nicotine, marijuana, alcohol
- •Any significant current medical or psychiatric condition
- •Known hypersensitivity to propylene glycol
- •Pregnant or lactating females
- •Uncontrolled asthma
- •Nut/e-liquid flavorant allergy
- •Current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms
- •Dislike of menthol flavor
研究组 & 干预措施
Non-menthol, nicotine 59mg/ml (1)
Flavor without menthol with 59mg/ml nicotine
干预措施: E-liquid coolant (No WS-3) for non-menthol (1) (Other)
Low (0.1%) menthol, nicotine 59mg/ml (1)
Flavor with low menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (No WS-3) for low (0.1%) menthol (1) (Other)
High (2.0%) menthol, nicotine 59mg/ml (1)
Flavor with high menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (No WS-3) for high (2.0%) menthol (1) (Other)
Non-menthol, nicotine 59mg/ml (2)
Flavor without menthol with 59mg/ml nicotine
干预措施: E-liquid coolant (Low [0.1%] WS-3) for non-menthol (2) (Other)
Low (0.1%) menthol, nicotine 59mg/ml (2)
Flavor with low menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (Low [0.1%] WS-3) for low (0.1%) menthol (2) (Other)
High (2.0%) menthol, nicotine 59mg/ml (2)
Flavor with high menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (Low [0.1%] WS-3) for high (2.0%) menthol (2) (Other)
Non-menthol, nicotine 59mg/ml (3)
Flavor without menthol with 59mg/ml nicotine
干预措施: E-liquid coolant (High [2.0%] WS-3) for non-menthol (3) (Other)
Low (0.1%) menthol, nicotine 59mg/ml (3)
Flavor with low menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (High [2.0%] WS-3) for low (0.1%) menthol (3) (Other)
High (2.0%) menthol, nicotine 59mg/ml (3)
Flavor with high menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (High [2.0%] WS-3) for high (2.0%) menthol (3) (Other)
Non-menthol, nicotine 59mg/ml (4)
Flavor without menthol with 59mg/ml nicotine
干预措施: E-liquid coolant (Low [0.1%] WS-23) for non-menthol (4) (Other)
Low (0.1%) menthol, nicotine 59mg/ml (4)
Flavor low menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (Low [0.1%] WS-23) for low (0.1%) menthol (4) (Other)
High (2.0%) menthol, nicotine 59mg/ml (4)
Flavor high menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (Low [0.1%] WS-23) for high (2.0%) menthol (4) (Other)
Non-menthol, nicotine 59mg/ml (5)
Flavor without menthol with 59mg/ml nicotine
干预措施: E-liquid coolant (High [2.0%] WS-23) for non-menthol (5) (Other)
Low (0.1%) menthol, nicotine 59mg/ml (5)
Flavor low menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (High [2.0%] WS-23) for low (0.1%) menthol (5) (Other)
High (2.0%) menthol, nicotine 59mg/ml (5)
Flavor high menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (High [2.0%] WS-23) for high (2.0%) menthol (5) (Other)
Non-menthol, nicotine 59mg/ml (6)
Flavor without menthol with 59mg/ml nicotine
干预措施: E-liquid coolant (4% WS-23) for non-menthol (6) (Other)
Low (0.1%) menthol, nicotine 59mg/ml (6)
Flavor low menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (4% WS-23) for low (0.1%) menthol (6) (Other)
High (2.0%) menthol, nicotine 59mg/ml (6)
Flavor high menthol concentration with 59mg/ml nicotine
干预措施: E-liquid coolant (4% WS-23) for high (2.0%) menthol (6) (Other)
结局指标
主要结局
Liking: Score change in liking/wanting of each e-cigarette condition (5 conditions in total)
时间窗: Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 6 (at 160 minutes)
The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from "most disliked sensation imaginable" to "most liked sensation imaginable" with higher values indicating greater liking).
Reinforcing Efficacy: Score change in drug effects of each e-cigarette condition (5 conditions in total)
时间窗: Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 6 (at 160 minutes)
Difference between e-cigarette effects for each e-cigarette condition as measured by the computerized version of the Drug Effects Questionnaire (DEQ). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. A modified version of the Drug Effects Questionnaire (DEQ) will be used in which participants rate acute responses to the e-cigarette on a 0-100mm scale from "not at all" (0mm) to "extremely" (100mm).
Irritation/Harshness: Score change in irritation of harshness of each e-cigarette condition (5 conditions in total)
时间窗: Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 6 (at 160 minutes)
Difference in irritation at each e-cigarette condition as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).
次要结局
- Craving: Change in craving score for e-cigarette from baseline at each e-cigarette condition (5 conditions in total)(At baseline (at 0 minute), following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 6 (at 160 minutes))
- Changes of salivary Nicotine and Cotinine Levels from baseline at each e-cigarette condition (6 conditions in total)(At baseline (at 0 minute), Following administration of e-cigarette condition 1 (at 10 minutes), following administration of e-cigarette condition 2 (at 40 minutes)...following administration of e-cigarette condition 6 (at 160 minutes))