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

Study Overview
=================
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.

Official Title
-----------------
Effects of Electronic Nicotine Delivery System Flavor Regulations on Tobacco Behavior, Toxicity, and Abuse Liability Among African American Menthol Smokers

Conditions
-----------------
Electronic Nicotine Delivery System Flavors

Intervention / Treatment
-----------------
* Other: Tobacco product administration and assessment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Menthol+Tobacco<br>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<br>* 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.<br>|
| Experimental: Tobacco<br>Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems | Other: Tobacco product administration and assessment<br>* 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.<br>|
| Experimental: Unflavored<br>Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems | Other: Tobacco product administration and assessment<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Daily Cigarette Use | Number of cigarettes used in the past day, collected via daily text survey, averaged over the past week | Week 1 vs. Week 6 | 
| Change in Carbon Monoxide Exposure | A biomarker of combusted cigarette use collected from exhaled breath | Week 1 vs. Week 6 | 
| Willingness to Substitute from Cigarettes to ENDS | Measure of substitution for condition-specific tobacco products will be assessed using drug purchase tasks. Choices made during this task are not reinforced. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electronic Nicotine Delivery System, Electronic Cigarette, Flavor, Abuse Liability, Toxicant Exposure, Tobacco, African American, Menthol