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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Electronic Nicotine Delivery System Flavors

Treatments: Other: Tobacco product administration and assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05023096

1R01DA050996-01A1 (U.S. NIH Grant/Contract)

HM20022060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

71 participants in 3 patient groups

Menthol+Tobacco

Active Comparator group

Description:

Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from

Treatment:

Other: Tobacco product administration and assessment

Tobacco

Experimental group

Description:

Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems

Treatment:

Other: Tobacco product administration and assessment

Unflavored

Experimental group

Description:

Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems

Treatment:

Other: Tobacco product administration and assessment