Nicotine Labeling for E-cigarettesNCT07553585
Survey to Test the Nicotine Concentration and Nicotine Flux Labels for E-cigarettes
A study testing Updated Labeling in people with Nicotine Labeling for E-cigarettes, run by Yale University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Labeling for E-cigarettes
- What is being tested?
- Updated Labeling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- Children under 14 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Grace Kong, PhD contact
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
Meghan Morean, PhD, 203-584-7197, meghan.morean@yale.edu
Suchitra Krishnan-Sarin, PhD, 203-974-7595, suchitra.krishnan-sarin@yale.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Nicotine Labeling for E-cigarettes
- Being tested
- Updated Labeling
- Keywords
- Nicotine Labeling, E-cigarette, Electronic Nicotine Delivery System, Nicotine Concentration, Nicotine Flux, Nicotine Emissions
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Updated LabelingOther
Flux based nicotine labeling.
| Study group | Role | What they receive |
|---|---|---|
| Flux Label 1 | Experimental | Participants may be randomized to view Version 1 of the flux label Receives: Other: Updated Labeling |
| Flux Label 2 | Experimental | Participants may be randomized to view Version 2 of the flux label Receives: Other: Updated Labeling |
| Flux Label 3 | Experimental | Participants may be randomized to view Version 3 of the flux label Receives: Other: Updated Labeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (2)
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).
Measured: 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).
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Labeling for E-cigarettesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553585
- Sponsor's protocol ID
- 2000042504
- Other IDs
- 1R01DA059573-01A1
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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. 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Novel Labeling to Improve Public Understanding of Nicotine in Electronic Nicotine Delivery Systems (ENDS): Nicotine Concentration and Nicotine Flux
- ClinicalTrials.gov ID
- NCT07553585
- Acronym / sponsor ID
- 2000042504
- Conditions
- Nicotine Labeling for E-cigarettes
- Keywords
- Nicotine Labeling, E-cigarette, Electronic Nicotine Delivery System, Nicotine Concentration, Nicotine Flux, Nicotine Emissions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Flux Label 1 | Experimental | Other: Updated LabelingParticipants may be randomized to view Version 1 of the flux label |
| Flux Label 2 | Experimental | Other: Updated LabelingParticipants may be randomized to view Version 2 of the flux label |
| Flux Label 3 | Experimental | Other: Updated LabelingParticipants may be randomized to view Version 3 of the flux label |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Youth* (14-20 years) or an adults (21 years and older)
- 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%).
Key exclusion criteria (1 listed)
- Children under 14 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Updated LabelingFlux based nicotine labeling. | Other | Flux Label 1, Flux Label 2, Flux Label 3 |
Primary outcome
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.
2 secondary outcomes
Perceived Addictiveness
Time frame: 20 minutes
Rank ordering of all labels on their ability to accurately convey information about nicotine strength
Time frame: 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: 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. 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
Related trials for Nicotine Labeling for E-cigarettes
Not yet recruiting
Abuse Liability for Eight Electronic Nicotine Products
Smoking, Smoking Behaviors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grace Kong, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Updated Labeling in people with Nicotine Labeling for E-cigarettes, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meghan E Morean, PhD (203-584-7197, meghan.morean@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Nicotine Strength (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.