Clinical trial NCT05023096: Potential Effects of Electronic Nicotine Delivery System Flavor Regulations on African American Menthol Smokers
Official title: Effects of Electronic Nicotine Delivery System Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability Among African American Menthol Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Nicotine Delivery System Flavors
Keywords: Electronic Nicotine Delivery System
Electronic Cigarette
Flavor
Abuse Liability
Toxicant Exposure
Tobacco
African American
Menthol
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-08-26
Enrollment: 71
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in Average Daily Cigarette Use
timeFrame: Week 1 vs. Week 6
measure: Change in Carbon Monoxide Exposure
timeFrame: Week 1 vs. Week 6
measure: Willingness to Substitute from Cigarettes to ENDS
timeFrame: Week 6
Secondary outcomes:
measure: Change in Average Daily ENDS Use
timeFrame: Week 1 vs. Week 6
measure: Change in NNAL Exposure
timeFrame: Week 1 vs. Week 6
measure: Change in Proplyne Glycol Exposure
timeFrame: Week 1 vs. Week 6
measure: Willingness to Pay for ENDS
timeFrame: Week 6
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Andrew J Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Caroline O Cobb, PhD
role: PRINCIPAL_INVESTIGATOR
References: