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
2 other identifiers
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedMarch 12, 2026
March 1, 2026
3.3 years
February 17, 2022
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Percent days smoke-free
From Week 0 to week 8
Changes in nicotine dependence using the Nicotine Dependence for Daily Smokers Scale
From Week 0 to week 8
Change in Quitting motivation and confidence
Week 0 and week 8
Quit intentions using the Stages of Change Assessment
Week 8
Other Outcomes (2)
Percent days of e-cigarette use
From Week 0 to week 8
Number of quit attempts during follow-up
Week 12
Study Arms (3)
no menthol ban
NO INTERVENTIONusual menthol cigarettes and menthol flavored e-cigarette available
menthol ban in cigarettes only
EXPERIMENTALnon-menthol cigarettes and menthol flavored e-cigarette available
menthol ban in both cigarettes and e-cigarettes
EXPERIMENTALnon-menthol cigarettes and tobacco flavored e-cigarette available,
Interventions
menthol ban in cigarettes only, menthol available in e-cigarette
menthol ban in both cigarettes and e-cigarettes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Yale University
New Haven, Connecticut, 06520, United States
Related Publications (1)
Bold KW, Sharma A, Haeny A, Gueorguieva R, Buta E, Baldassarri S, Lempert L, Krishnan-Sarin S, O'Malley S. A randomized controlled trial of potential tobacco policies prohibiting menthol flavor in cigarettes and e-cigarettes: a study protocol. BMC Psychiatry. 2024 Mar 12;24(1):201. doi: 10.1186/s12888-024-05619-0.
PMID: 38475757DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krysten Bold, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2022
First Posted
February 28, 2022
Study Start
December 1, 2022
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- 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.
- 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.
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.