Potential Impact of Menthol Ban in Cigarettes and E-cigarettes

NCT ID: NCT05259566

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2026-03-31

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.

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.

Conditions

Tobacco Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

no menthol ban

usual menthol cigarettes and menthol flavored e-cigarette available

Group Type: NO_INTERVENTION

No interventions assigned to this group

menthol ban in cigarettes only

non-menthol cigarettes and menthol flavored e-cigarette available

Group Type: EXPERIMENTAL

menthol ban in cigarettes only

Intervention Type: BEHAVIORAL

menthol ban in cigarettes only, menthol available in e-cigarette

menthol ban in both cigarettes and e-cigarettes

non-menthol cigarettes and tobacco flavored e-cigarette available,

Group Type: EXPERIMENTAL

total menthol ban

Intervention Type: BEHAVIORAL

menthol ban in both cigarettes and e-cigarettes

Interventions

menthol ban in cigarettes only

menthol ban in cigarettes only, menthol available in e-cigarette

Intervention Type: BEHAVIORAL

total menthol ban

menthol ban in both cigarettes and e-cigarettes

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krysten Bold, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Krysten Bold, PhD

Role: CONTACT

Krysten.bold@yale.edu

203-974-7603

References

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.

Reference Type: DERIVED

PMID: 38475757 (View on PubMed)

Other Identifiers

1R01DA054993-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000032211

Identifier Type: -

Identifier Source: org_study_id