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N/A Completed N=71 Randomized Basic Science

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

Electronic Nicotine Delivery System Flavors
Source: ClinicalTrials.gov NCT05023096 ↗
Enrolled (actual)
71
Serious AEs
2.8%
Results posted
Apr 2026
Primary outcomePrimary: Average Daily Cigarette Use — 10.3; 17.3; 12.3; 5.3 number of cigarettes per day

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.

Outcome Measures

OutcomeResultp-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

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. Informational only — not medical advice.

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