Potential Impact of Menthol Ban in Cigarettes and E-cigarettes

Evaluating the Potential Impact of a Menthol Ban in Cigarettes and E-cigarettes Among Current Menthol Smokers

Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban. The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Smoking
• Intervention / Treatment: Behavioral: menthol ban in cigarettes only; Behavioral: total menthol ban

Detailed Description

Menthol cigarette use remains a major public health problem and the FDA has proposed to ban menthol in cigarettes. However, additional evidence is needed to understand whether menthol flavor in e-cigarettes is important for harm reduction among menthol cigarette smokers in the context of a menthol cigarette ban.

The primary aim of this project is to understand how the availability of menthol vs tobacco flavor e-cigarettes influences switching and reduces smoking behavior among adults who currently smoke menthol cigarettes to understand the potential effects in the context of a ban of menthol cigarettes. The secondary aim of this project is to understand whether smoking behavior outcomes differ by race to understand the impact of these potential menthol ban policies on addressing tobacco-related health disparities.

This single site study will take place over a 4 year study period; approximately 14 weeks for each participant's completion.

150 adults who currently smoke menthol cigarettes will be enrolled and prospectively randomized using a randomization ratio of 1:1:1 to 1 of 3 groups (N=50 per group). Following an initial baseline period where participants have access to their usual menthol cigarettes (Phase I), participants will receive tobacco products to use for 8 weeks based on their assigned group modeling 3 possible regulatory scenarios (Phase II): 1) no menthol ban (menthol cigarettes and e-cigarettes available), 2) menthol ban in cigarettes only (non-menthol cigarettes and menthol e-cigarettes available), 3) menthol ban in both cigarettes and e-cigarettes (non-menthol cigarettes and tobacco e-cigarettes available). A follow-up survey at week 12 will assess tobacco use outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Krysten Bold, PhD; Phone Number: 203-974-7603; Email: Krysten.bold@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Age 21 or older
• Able to read English
• Currently smoking cigarettes
• Willing to try e-cigarettes
• In good general health

Exclusion Criteria:

• Seeking smoking cessation treatment
• Serious psychiatric or medical condition
• Use of other drugs
• Unable or unwilling to complete study protocol
• Contraindications for study procedures based on medical history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: no menthol ban; usual menthol cigarettes and menthol flavored e-cigarette available
Experimental: menthol ban in cigarettes only; non-menthol cigarettes and menthol flavored e-cigarette available	Behavioral: menthol ban in cigarettes only; menthol ban in cigarettes only, menthol available in e-cigarette
Experimental: menthol ban in both cigarettes and e-cigarettes; non-menthol cigarettes and tobacco flavored e-cigarette available,	Behavioral: total menthol ban; menthol ban in both cigarettes and e-cigarettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of cigarettes smoked per day in the past week to evaluate changes in smoking behavior	Participants will report the total number of cigarettes consumed each day using the well-validated timeline follow-back (TLFB) interview methods to assess change.	From Week 0 to week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent days smoke-free	Participants will report the number of smoke free days over the 8 week study period. Percent days smoke-free will be determined using the TLFB interview methods.	From Week 0 to week 8
Changes in nicotine dependence using the Nicotine Dependence for Daily Smokers Scale	Changes in nicotine dependence will be measured using the Nicotine Dependence for Daily Smokers Scale from the NIH Patient Reported Outcome Measure Information System (PROMIS) bank. Scores are averaged across 4 items, min=1, max=5. Higher scores indicate greater nicotine dependence.	From Week 0 to week 8
Change in Quitting motivation and confidence	Quitting motivation and confidence will be assessed using the PhenX Toolkit using the items "How motivated are you to quit smoking?" and "How confident are you that you could quit smoking if you tried?" rated from 1 (not at all) to 10 (extremely).	Week 0 and week 8
Quit intentions using the Stages of Change Assessment	Participants will report their plans to quit smoking in the next 30 days based on Stages of Change Assessment, on a scale from 0 (I have absolutely no intention of quitting smoking) to 10 (I have made a firm decision to quit in the next 30 days). Higher scores indicate the more intention to quit.	Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent days of e-cigarette use	Participants will report the number of days using the e-cigarette over the 8 week study period using the TLFB interview	From Week 0 to week 8
Number of quit attempts during follow-up	Number of quit attempts at the 12-week follow-up, measured by the TLFB interview methods.	Week 12

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Krysten Bold, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cigarette; E-cigarette; menthol
• Additional Relevant MeSH Terms: Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: 2000032211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study data is collected and cleaned, and the primary paper is published, de-identified study data will be available for research purposes to qualified individuals within the scientific community by request from the PI or through the National Addiction & HIV Data Archive Program (NAHDAP) an NIH-funded repository, consistent with NIH guidelines for the timely release and sharing of resources. Additional data documentation and codebooks defining relevant variables, terminology, and scoring guidelines for scale scores will be deposited and made available for sharing along with de-identified data.
• IPD Sharing Time Frame: After the study data is collected and cleaned, and the primary paper is published, de-identified study data will be made available to individuals within the scientific community by request from the PI or through NIH data repository.
• IPD Sharing Access Criteria: As we plan to use NAHDAP, which is an NIH-funded repository, this repository has policies and procedures in place that will provide access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No