Nicotine Labeling for E-cigarettes
Conditions
Keywords
Nicotine Labeling, E-cigarette, Electronic Nicotine Delivery System, Nicotine Concentration, Nicotine Flux, Nicotine Emissions
Brief summary
Current labels for the nicotine in e-cigarette/vaping products do not sufficiently convey information to the public. The aims of this study include developing and validating two new types of labels for the nicotine in vaping products: nicotine concentration and nicotine flux (reflecting nicotine emissions). Investigators will survey youth (ages 14-20) and adults (ages 21+ \[21 is the legal age to purchase tobacco products in the U.S.\]) to evaluate the utility of several new labels investigators have developed.
Detailed description
The primary goal of the proposed study is to improve labeling of the nicotine in e-cigarettes so that both youth and adults better understand the nicotine strength of these products. Aims include: 1) developing a universally-applicable nicotine concentration label that provides more information than does current market labeling, and 2) examining the utility of labeling nicotine flux (i.e., the nicotine produced through the product mouthpiece) for closed-system e-cigarettes relative to current market labeling and the new nicotine concentration labeling. This study has three primary objectives. First, to produce an optimized nicotine concentration label that could be used to replace current FDA-mandated nicotine concentration labeling for all ENDS. Second, to develop optimized nicotine flux labeling for closed-system devices for which flux values are readily calculatable. Third, to compare the optimized nicotine concentration and flux labels to one another to determine if there is added value of including flux labeling on closed system devices. Given that flux labels have never been developed before, the proposed study will be the first to speak to their potential utility.
Interventions
OTHERUpdated Labeling
Flux based nicotine labeling.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
All participants will be randomized to view 1 of 3 label types for nicotine flux to reduce participant burden and to prevent participants from learning information from one of the flux labels and applying it the subsequent label(s).
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Youth\* (14-20 years) or an adults (21 years and older) * The legal age for purchasing tobacco in the U.S. is 21 years. Therefore, ages for youth and adults were split at the legal age for purchase. * Resides in the United States * Reports no history of tobacco product use (25% of the youth and adult samples, respectively) or past-month use of e-cigarettes (but not cigarettes; 25%), cigarettes (but not e-cigarettes; 25%), or both e-cigarettes and cigarettes (25%).
Exclusion criteria
* Children under 14 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Nicotine Strength | 20 minutes | To assess the impact of the new labels on understanding of the nicotine strength of e-cigarettes, perceived nicotine strength will be assessed. Participants will see each label at four nicotine strengths. After viewing each label/strength combination, participants will report on perceived strength. A correct response will be one that corresponds to what the label depicts. For instance, a response of "high nicotine" would be correct if a flux label visually depicts nicotine emissions in the high range. The total number of correct strength ratings for each label type (i.e., the market mg/mL label, the new nicotine concentration labels, the new flux labels) will be calculated and compared to one another to determine which label is most informative. The primary hypothesis is that the new nicotine concentration and flux label(s) will outperform mg/mL market labeling in accurately conveying liquid nicotine strength. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Addictiveness | 20 minutes | The labels are designed to be informational at their core and increase understanding of nicotine strength. However, information about other features like perceived product addictiveness may also be conveyed by the labels. Thus, after reporting on perceived nicotine strength for each label type/strength combination, participants will report of perceived addictiveness of the product (response options: not addictive, slightly addictive, moderately addictive, very addictive, extremely addictive, and I don't know). Compared to current market labels at a given strength/emissions level, the new nicotine concentration and flux labels are expected to be associated with higher ratings of addictive potential, especially at higher strength/emissions levels and among youth (Secondary Hypothesis 1). |
| Rank ordering of all labels on their ability to accurately convey information about nicotine strength | 20 minutes | All participants will view a page that simultaneously displays all six label types (i.e., the current market label, the two new nicotine concentration labels, all three flux labels) and rank order the labels from best (#1) to worst (#6) in terms of their ability to communicate information about nicotine strength. Because participants are randomized to provide perceived strength and addictiveness ratings for only 1 of 3 nicotine flux labels, this outcome measure will provide a secondary way to examine informativeness in which participants are exposed to all labels types prior to making their ratings. Participants are expected to prefer the new nicotine concentration label and the flux labels over mg/mL alone for communicating information about strength (Secondary Hypothesis 2). |
Countries
United States
Contacts
CONTACTMeghan E Morean, PhD
CONTACTGrace Kong, PhD
Outcome results
None listed