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OpenTrials
Completed

NCT Number: NCT05023096

Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers

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.

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Key information

Conditions

Electronic Nicotine Delivery System Flavors Behavior Smoking Vaping

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 21+ 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 3 months
  • 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
  • unstable or significant medical condition in the past 12 months
  • 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

Treatment and study plan

Tobacco product administration and assessment

Other

Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.

Primary outcomes

  1. Average Daily Cigarette Use

    Time frame: Randomization and Week 6

    Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week

  2. Carbon Monoxide Exposure

    Time frame: Randomization and Week 6

    A biomarker of combusted cigarette use collected from exhaled breath.

  3. Willingness to Substitute From Cigarettes to ENDS

    Time frame: Week 6

    CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios involving their own brand cigarettes and condition-specific ENDS. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a their conditions-specific ENDS they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each ENDS puff cost $0.10. The outcome of the task is the willingness to pay in USD for each ENDS puff.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Effects of Electronic Nicotine Delivery System Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability Among African American Menthol Smokers (RVA Flavors)

Acronym: RVA Flavors

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2021
Registry last updated
Apr 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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