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

NCT05023096 | Completed Results

• 2 other identifiers: HM200220601R01DA050996-01A1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Electronic Nicotine Delivery System Flavors

Keywords

Electronic Nicotine Delivery System; Electronic Cigarette; Flavor; Abuse Liability; Toxicant Exposure; Tobacco; African American; Menthol

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Menthol+Tobacco

ACTIVE COMPARATOR

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

Tobacco

EXPERIMENTAL

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

Other: Tobacco product administration and assessment

Unflavored

EXPERIMENTAL

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

Other: Tobacco product administration and assessment

Interventions

Tobacco product administration and assessment 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.

Menthol+Tobacco; Tobacco; Unflavored

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Results Point of Contact

• Title: Caroline Cobb, Associate Professor
• Organization: Virginia Commonwealth University

cobbco@vcu.edu

804-828-1867

Study Officials

• Andrew J Barnes, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Caroline O Cobb, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: April 14, 2022
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Locations

US (1)