Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers (RVA Flavors)

  • STATUS
    Recruiting
  • End date
    Jun 15, 2024
  • participants needed
    210
  • sponsor
    Virginia Commonwealth University
Updated on 4 October 2022
Accepts healthy volunteers

Summary

This study aims to better understand how the availability of electronic nicotine delivery system (aka electronic cigarettes) flavors (e.g., menthol, tobacco) impacts tobacco use behaviors, toxicant exposure, and abuse liability among African American menthol smokers.

Description

Black/African American (AA) menthol smokers are disproportionately harmed by tobacco products and could experience significant health benefits from increased availability of well-regulated electronic nicotine delivery systems (ENDS). The current study will evaluate whether ENDS flavor availability affects measures of tobacco use, biomarkers of cigarette/ENDS exposure, and addiction among AA menthol smokers by performing a 3-arm, 6-week clinical trial of ENDS provision with follow-up to 30 days. Results of this work will help FDA make predictions about the impact of moving from the current regulatory market were menthol/tobacco flavored ENDS cartridges are available, to one where only tobacco or unflavored cartridges are available, in order to maximize health-promoting effects and minimize unintended consequences among AA menthol smokers.

Details
Condition Electronic Nicotine Delivery System Flavors
Treatment Tobacco product administration and assessment
Clinical Study IdentifierNCT05023096
SponsorVirginia Commonwealth University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

+ years of age
identify as Black/African American (single or multi-race)
have used ≥5 cigarettes per day for ≥1 year
biochemically confirmed cigarette smoking status
regular cigarette brand is flavored to taste like menthol or mint
ENDS use in the past 30 days
report no intent to quit smoking in the next 6 months
previous quit attempt using evidence-based method
have a working mobile phone with a texting/data plan
are willing receive phone calls/text messages and complete internet-based/online surveys related to the study
read and write in English

Exclusion Criteria

are unwilling to use ENDS as part of the trial
report other tobacco use >10 days in past 30 other than cigarettes
unstable or significant medical condition in the past 12 months
report >15 days of marijuana use in the past 30 days
report any other illegal drug use in past 30 days
report intent to become pregnant or current pregnancy/breastfeeding
report any other condition that may affect participant safety or not allow them to fully participate in the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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