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

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

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.

Study Overview

• Status: Completed
• Conditions: Electronic Nicotine Delivery System Flavors
• Intervention / Treatment: Other: Tobacco product administration and assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Menthol+Tobacco; Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from	Other: Tobacco 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.
Experimental: Tobacco; Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems	Other: Tobacco 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.
Experimental: Unflavored; Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems	Other: Tobacco 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Average Daily ENDS Use	Number of ENDS puffs in the past day, collected via daily text survey, averaged over the past week	Week 1 vs. Week 6
Change in NNAL Exposure	A biomarker of combusted cigarette use collected from urine	Week 1 vs. Week 6
Change in Proplyne Glycol Exposure	A biomarker of ENDS use collected from urine	Week 1 vs. Week 6
Willingness to Pay for ENDS	Willingness to pay for condition-specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced.	Week 6

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Andrew J Barnes, PhD, Virginia Commonwealth University; Principal Investigator: Caroline O Cobb, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Tobacco; African American; Electronic Nicotine Delivery System; Menthol; Electronic Cigarette; Abuse Liability; Flavor; Toxicant Exposure
• Additional Relevant MeSH Terms: Behavior; Smoking; Vaping; Investigative Techniques; Therapeutics; Behavior Control; Immobilization; Restraint, Physical
• Other Study ID Numbers: HM20022060; 1R01DA050996-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No