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NCT Number: NCT07553585

Survey to Test the Nicotine Concentration and Nicotine Flux Labels for E-cigarettes

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location contact

Grace Kong, PhD

SUB_INVESTIGATOR

Meghan Morean, PhD

CONTACT

[email protected]

203-584-7197

Meghan Morean, PhD

PRINCIPAL_INVESTIGATOR

Suchitra Krishnan-Sarin, PhD

CONTACT

[email protected]

203-974-7595

Suchitra Krishnan-Sarin, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Updated Labeling

Other

Flux based nicotine labeling.

Primary outcomes

  1. Perceived Nicotine Strength

    Time frame: 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 outcomes

  1. Perceived Addictiveness

    Time frame: 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).

  2. Rank ordering of all labels on their ability to accurately convey information about nicotine strength

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Kong, PhD

CONTACT

[email protected]

Meghan E Morean, PhD

CONTACT

[email protected]

203-584-7197

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Using Novel Labeling to Improve Public Understanding of Nicotine in Electronic Nicotine Delivery Systems (ENDS): Nicotine Concentration and Nicotine Flux

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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