Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes

Summary

In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.

Conditions

• Smoking Prevention and Control

Interventions

BEHAVIORAL

Non-Menthol Cigarettes

Ppts will be randomly assigned to a group that receives non-menthol cigarettes

BEHAVIORAL

Tobacco Flavored E-cigarettes

Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes

BEHAVIORAL

Menthol Cigarettes

Ppts will be randomly assigned to a group that receives menthol flavored cigarettes

BEHAVIORAL

Menthol Flavored E-cigarettes

Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• University of Minnesota

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Medical University of South Carolina

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-23

Primary Completion

2027-06-30

Completion

2027-08-31

Countries

• United States

Study Locations