An interventional study of Updated Labeling in Nicotine Labeling for E-cigarettes, sponsored by Yale University. Not yet recruiting at 1 site in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Yale University · Not applicable, Interventional, and Other
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.
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.
402 studies on the registry are indexed under Vaping; 95 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 79 across 322 interventional studies indexed under Vaping.
Browse Vaping studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Youth* (14-20 years) or an adults (21 years and older)
Exclusion Criteria:
Participants may be randomized to view Version 1 of the flux label
Other: Updated Labeling
Participants may be randomized to view Version 2 of the flux label
Other: Updated Labeling
Participants may be randomized to view Version 3 of the flux label
Other: Updated Labeling
Flux based nicotine labeling.
Perceived Nicotine Strength
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.
Time frame: 20 minutes
Perceived Addictiveness
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).
Time frame: 20 minutes
Rank ordering of all labels on their ability to accurately convey information about nicotine strength
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).
Time frame: 20 minutes
Plan to share: Yes — As outlined in the data management and sharing plan, the following data will be shared on openICPSR, which supports user-friendly search terms (e.g., by PI name, project title, keywords) and assigns a persistent digital object identifier (DOI) to all projects. The anonymous survey data A codebook explaining variables An annotated syntax file that outlines how variables were coded/created Syntax for the central study analyses that were conducted
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be made available no later than the time of an associated publication or the end of the performance period, whichever comes first. Data will be available indefinitely.
Access criteria: Data may be obtained after a user agrees to abide by all ICPSR licensing terms. Further, prior to downloading data, users must agree "1) To not use the datasets for investigation of specific research subjects, except when identification is authorized in writing by ICPSR (which is not applicable to the proposed project); 2) To make no use of the identity of any research subject discovered inadvertently (which is not applicable to the proposed project), and 3) to advise ICPSR of any such discovery."
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
Of 184 non-industry interventional studies with no phase under Vaping, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 2 months is below that.
Counting every sponsor, half of 208 studies reached it within 18 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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