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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nicotine Labeling for E-cigarettes
• Intervention / Treatment: Other: Updated Labeling

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.

• Study Type: Interventional
• Enrollment (Estimated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghan E Morean, PhD; Phone Number: 203-584-7197; Email: meghan.morean@yale.edu
• Study Contact Backup: Name: Grace Kong, PhD; Email: grace.kong@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Connecticut Mental Health Center
      • Contact: Suchitra Krishnan-Sarin, PhD; Phone Number: 203-974-7595; Email: suchitra.krishnan-sarin@yale.edu
      • Contact: Meghan Morean, PhD; Phone Number: 203-584-7197; Email: meghan.morean@yale.edu
      • Principal Investigator: Meghan Morean, PhD
      • Sub-Investigator: Grace Kong, PhD
      • Sub-Investigator: Suchitra Krishnan-Sarin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flux Label 1; Participants may be randomized to view Version 1 of the flux label	Other: Updated Labeling; Flux based nicotine labeling.
Experimental: Flux Label 2; Participants may be randomized to view Version 2 of the flux label	Other: Updated Labeling; Flux based nicotine labeling.
Experimental: Flux Label 3; Participants may be randomized to view Version 3 of the flux label	Other: Updated Labeling; Flux based nicotine labeling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	20 minutes

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Electronic Nicotine Delivery System; Nicotine Flux; E-cigarette; Nicotine Labeling; Nicotine Concentration; Nicotine Emissions
• Additional Relevant MeSH Terms: Behavior; Smoking; Vaping
• Other Study ID Numbers: 2000042504; 1R01DA059573-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

1. The anonymous survey data
2. A codebook explaining variables
3. An annotated syntax file that outlines how variables were coded/created
4. Syntax for the central study analyses that were conducted

• IPD Sharing 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.
• IPD Sharing 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."
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No