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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05023096

Acronym

RVA Flavors

Enrollment

Registered

2021-08-26

Start date

2022-04-14

Completion date

2024-10-15

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electronic Nicotine Delivery System Flavors

Keywords

Electronic Nicotine Delivery System, Electronic Cigarette, Flavor, Abuse Liability, Toxicant Exposure, Tobacco, African American, Menthol

Brief 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.

Detailed 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.

Interventions

OTHERTobacco product administration and assessment

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Average Daily Cigarette Use	Randomization and Week 6	Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week
Carbon Monoxide Exposure	Randomization and Week 6	A biomarker of combusted cigarette use collected from exhaled breath.
Willingness to Substitute From Cigarettes to ENDS	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAndrew J Barnes, PhD

Virginia Commonwealth University

PRINCIPAL_INVESTIGATORCaroline O Cobb, PhD