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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05023096

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

210

Enrollment

Location

Arms

25.6

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Electronic Nicotine Delivery System Flavors	Other: Tobacco product administration and assessment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Apr 14, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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.

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

Experimental: Unflavored

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

Other: Tobacco product administration and assessment

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 30 days
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
report other tobacco use >10 days in past 30 other than cigarettes
unstable or significant medical condition in the past 12 months
report >15 days of marijuana use in the past 30 days
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