Survey to Test the Nicotine Concentration and Nicotine Flux Labels for E-cigarettes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Updated Labeling.
- Who it may be relevant to
- Registry conditions: Nicotine Labeling for E-cigarettes. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using Novel Labeling to Improve Public Understanding of Nicotine in Electronic Nicotine Delivery Systems (ENDS): Nicotine Concentration and Nicotine Flux
Overview
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
- Other Updated Labeling
Flux based nicotine labeling.
Primary outcome measures
- Perceived Nicotine Strength [Time frame: 20 minutes]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Connecticut Mental Health Center — New Haven
Identifiers
NCT: NCT07553585 · 2000042504 · 1R01DA059573-01A1