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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05896033

Collaborator

National Institutes of Health (NIH) (NIH), University of Minnesota (Other), National Institute on Drug Abuse (NIDA) (NIH)

240

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Prevention and Control	Behavioral: Non-Menthol Cigarettes Behavioral: Tobacco Flavored E-cigarettes Behavioral: Menthol Cigarettes Behavioral: Menthol Flavored E-cigarettes	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.	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
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.	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
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.	Behavioral: Non-Menthol Cigarettes Ppts will be randomly assigned to a group that receives non-menthol cigarettes Behavioral: Menthol Flavored E-cigarettes Ppts will be randomly assigned to a group that receives menthol flavored e-cigarettes
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.	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

Outcome Measures

Primary Outcome Measures

Changes in cigarettes per day [Week 1- Week 6]
Will be measured through week 6 of the study

Secondary Outcome Measures

Fagerstrom Test for Nicotine Dependence [Week 1- Week 7]
Cigarette Dependence
Ability to abstain from smoking [Week 7]
Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

adults (21+) who a) have been smoking at least 5 cigarettes daily for one year
usual brand (the brand used most often) is mentholated
have a smartphone that can receive text messages and access the internet (necessary for diary completion).

Exclusion Criteria:

other tobacco and pharmacotherapy criteria
health and safety criteria
planning to move out of the area within the next 3 months

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of South Carolina
National Institutes of Health (NIH)
University of Minnesota
National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tracy Smith, Associate Professor-Faculty, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT05896033

Other Study ID Numbers:

00122898
1R01DA055985-01A1

First Posted:

Jun 9, 2023

Last Update Posted:

Jun 9, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tracy Smith, Associate Professor-Faculty, Medical University of South Carolina

Smoking

Menthol

Additional relevant MeSH terms:

Menthol

Study Results

No Results Posted as of Jun 9, 2023