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

Conditions

• Smoking Prevention and Control

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Non-Menthol Cigarettes — BEHAVIORAL
  Ppts will be randomly assigned to a group that receives non-menthol cigarettes
• Tobacco Flavored E-cigarettes — BEHAVIORAL
  Ppts will be randomly assigned to a group that receives tobacco flavored e-cigarettes
• Menthol Cigarettes — BEHAVIORAL
  Ppts will be randomly assigned to a group that receives menthol flavored cigarettes
• Menthol Flavored E-cigarettes — BEHAVIORAL
  Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes

Study Details

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.

Key Dates

Start date

Oct 23, 2023

Status verified

Mar 2026

Primary completion

Jun 30, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Arms

• Experimental: Menthol Spectrum Cigarettes and Menthol E-cigarettes
  Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
• Experimental: Menthol Spectrum Cigarettes and Tobacco E-cigarettes
  Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
• Experimental: Non-menthol Spectrum Cigarettes and Menthol E-cigarettes
  Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.
• Experimental: Non-menthol Spectrum Cigarettes and Tobacco E-cigarettes
  Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.

Primary Outcome Measure

Changes in cigarettes per day [ Time Frame: Week 1- Week 6 ]

Central Contacts

• Tracy T Smith
  8437925164
  [email protected]

Locations (1)

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