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

NCT ID: NCT05023096

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2024-10-15

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.

Conditions

Electronic Nicotine Delivery System Flavors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Menthol+Tobacco

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

Group Type: ACTIVE_COMPARATOR

Tobacco product administration and assessment

Intervention Type: OTHER

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.

Tobacco

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

Group Type: EXPERIMENTAL

Tobacco product administration and assessment

Intervention Type: OTHER

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.

Unflavored

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

Group Type: EXPERIMENTAL

Tobacco product administration and assessment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew J Barnes, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Caroline O Cobb, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

1R01DA050996-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20022060

Identifier Type: -

Identifier Source: org_study_id