Center for the Study of Tobacco Products
Richmond, Virginia, 23220, United States
NCT Number: NCT05971823
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Richmond, Virginia, 23220, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment.
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: 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.
Virginia Commonwealth University
Other
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