Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Pmax of Drug Purchase Task (DPT)
研究概览
简要总结
The purpose of this study is to determine if abuse liability indices will be impacted by varying flavors and e-cigarette (ECIG) nicotine delivery capability (i.e., nicotine flux) among current combustible cigarette users.
The investigators will compare abuse liability indices between three FDA-authorized ECIG products that vary in nicotine flux (but are all tobacco flavor) and own brand cigarettes. The investigators will also test the influence of ECIG flavor availability (tobacco vs. menthol) within three ECIG product classes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None (Participant)
盲法说明
Participants will be blinded to device nicotine concentration and flavor used during ECIG sessions. No blinding will occur for the own brand condition.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy (determined by self-report)
- •at least 18 years old
- •willing to provide informed consent
- •able to attend the lab and use designated products according to the study protocol
- •smoke cigarettes at least 3 days per week, and on those days, at least one cigarette is smoked per day
- •positive urine cotinine test
排除标准
- •Women who are breastfeeding or test positive for pregnancy (by urinalysis) at screening.
- •Individuals with the following self-reported current, diagnosed medical condition(s) will be excluded automatically: uncontrolled high blood pressure (via self-report or observed at screening; BP must be less than 160/100), heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures.
- •Individuals with other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, lyme disease) will be considered for exclusion after consultation with the PI and medical monitor. We ask a variety of questions about participants' medical conditions that are not necessarily exclusionary to be able to consult with the medical monitor about these conditions. Participants with any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations.
- •Individuals with current, diagnosed, uncontrolled psychiatric conditions will be excluded. A controlled psychiatric illness is defined as one where the individual is taking medication and/or receiving other treatment (e.g., psychotherapy). In addition, individuals who have been to the ER and/or been hospitalized for a psychiatric condition in the past year will be excluded. Individuals with past-month use of cocaine, opioids, benzodiazepines, and methamphetamine or other illegal substances (other than cannabis) will be excluded. Individuals who report using cannabis more than 15 days in the past 30 and/or alcohol more than 25 days in the past 30 days will be excluded.
- •Participants who choose not to answer questions related to inclusion/exclusion criteria will be excluded.
- •Participants who indicate their sex assigned at birth is female will be excluded if they are breastfeeding or test positive for pregnancy (by urinalysis) at screening.
研究组 & 干预措施
All Participants
All participants will receive the same interventions in the same order.
干预措施: Tobacco product administration and assessment (Other)
结局指标
主要结局
Pmax of Drug Purchase Task (DPT)
时间窗: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.
Intensity of Drug Purchase Task (DPT)
时间窗: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.
Cross-price elasticity of the Cross Product-DPT
时间窗: Each CP-DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices.
Breakpoint of Drug Purchase Task (DPT)
时间窗: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.
Elasticity of Drug Purchase Task (DPT)
时间窗: Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.
Omax of Drug Purchase Task (DPT)
时间窗: A DPT will be Each DPT will be completed twice per study session, about 55 minutes into the session and again at 120 minutes into the session once for each arm.
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session.
Intensity of Drug Purchase Task (DPT)
时间窗: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Order effects are not assessed in this study design. Intensity, as measured by DPT, is a self-report measure used to assess the reinforcing efficacy or motivational value of a substance. It is a specific quantitative index that refers to the maximum amount of a drug a person would consume if it were available at zero or minimal cost. For this assessment, intensity is measured in puffs (e.g., 0-100 puffs if each puff were free).
Price Sensitivity of Drug Purchase Task (DPT)
时间窗: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Order effects are not assessed in this study design. Price sensitivity (α; change in amount purchased as price increases) as measured by DPT. By analyzing these metrics, researchers can quantify and compare the motivational strength and reinforcing value of different substances or different doses, providing insight into the overvaluation of drugs that contributes to addiction. (e.g., 0% to 1% range) DPT outcomes included: breakpoint (highest price participants were willing to pay), intensity (consumption at zero cost), and price sensitivity (α; change in amount purchased as price increases
Breakpoint of Drug Purchase Task (DPT)
时间窗: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Order effects are not assessed in this study design. Breakpoint, as measured by DPT, is defined as the first price at which a participant's consumption of a hypothetical drug product is suppressed to zero. The DPT is a behavioral economics assessment tool used to measure the reinforcing value (or abuse liability) of substances. Participants are asked to report how much of a drug they would consume at a series of escalating prices, assuming no access to other similar products and that all consumption would occur within a specified time period (e.g., one day). (e.g. $0.00 to $10.00 range)
Cross-price Elasticity of the Cross Product-DPT
时间窗: There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices. Order effects are not assessed in this study design. CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a menthol-flavored NJOY Ace 2.4% Nicotine ECIG they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each menthol-flavored NJOY Ace 2.4% Nicotine ECIG puff cost $0.10.The outcome of the task is cross-price elasticity.
次要结局
未报告次要终点