N/A N=71 Randomized Basic Science

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

Electronic Nicotine Delivery System Flavors

Bottom Line

View on ClinicalTrials.gov: NCT05023096 ↗

Enrolled (actual)

Serious AEs

2.8%

Results posted

Apr 2026

Primary outcome: Primary: Average Daily Cigarette Use — 10.3; 17.3; 12.3; 5.3 number of cigarettes per day

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Tobacco product administration and assessment (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Virginia Commonwealth University
Primary completion: Oct 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Daily Cigarette Use	10.3; 17.3; 12.3; 5.3; 5.9; 5.6	—
PRIMARY Carbon Monoxide Exposure	19.5; 25.5; 21.5; 17.7; 25.0; 20.4	—
PRIMARY Willingness to Substitute From Cigarettes to ENDS	.41; -.054; -.055	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05023096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.