ClinicalTrials.gg
RecruitingNCT05896033Updated Jul 21, 2026

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

An interventional study of Non-Menthol Cigarettes and Tobacco Flavored E-cigarettes in Smoking Prevention and Control, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years later.

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Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 30 studies in Smoking by Medical University of South Carolina — 8 open to participants now, 8 under way, none of them phase 3. Smoking · Medical University of South Carolina.

Planned enrollment
9th of 29
240 · median 99
Started
2023
the only one that year
No phase
23 of 30
7 open now
Registered
24th of 30
by date

Among the 30 studies in Smoking by Medical University of South Carolina, this one is the 9th largest by planned enrollment of the 29 interventional ones that give a count, is the only one that started in 2023, is one of 23 with no phase, and was the 24th registered.

Smoking

1,510 studies on the registry are indexed under Smoking; 193 are open to participants now.

Browse Smoking studies →

Open to participants now

8 of the 30 studies in Smoking by Medical University of South Carolina are open now, in 1 country. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 140 Smoking studies recruiting now, 74 (53%) set no upper age limit and 48 (34%) stop at 75 or younger; 3 take children under 18; 65 take healthy volunteers.

This study: 21 Years and older · all sexes · healthy volunteers too.

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02

Study 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.

03

Conditions studied

  • Smoking Prevention and Control

Browse trials for

Keywords

  • Smoking
  • Menthol
04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. other tobacco and pharmacotherapy criteria
  2. health and safety criteria
  3. planning to move out of the area within the next 3 months
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study 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.

    Behavioral: Menthol Cigarettes · Behavioral: 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 · Behavioral: Menthol 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 · Behavioral: 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 · Behavioral: Tobacco Flavored E-cigarettes

Interventions

  • BehavioralNon-Menthol Cigarettes

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

  • BehavioralTobacco Flavored E-cigarettes

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

  • BehavioralMenthol Cigarettes

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

  • BehavioralMenthol Flavored E-cigarettes

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

06

What researchers measure

Primary outcomes

  1. Changes in cigarettes per day

    Will be measured through week 6 of the study

    Time frame: Week 1- Week 6

Secondary outcomes

  1. Fagerstrom Test for Nicotine Dependence

    Cigarette Dependence

    Time frame: Week 1- Week 7

  2. Ability to abstain from smoking

    Participants will complete a 1-week practice quit attempt in week 7; time to first smoking lapse will be assessed.

    Time frame: Week 7

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Jun 2027, 44 months after the start.

Of 402 non-industry interventional studies with no phase under Smoking, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 44 months is above that.

Counting every sponsor, half of 457 studies reached it within 23 months; a quarter within 8 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2023
First posted
Jun 9, 2023
StartActual
Oct 23, 2023
Primary completionEst.
Jun 30, 2027
CompletionEst.
Aug 31, 2027
Last update
Jul 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05896033
Responsible party
Sponsor
First posted
Jun 9, 2023
Start date
Oct 23, 2023
Primary completion
Jun 30, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Jul 21, 2026

Study contacts

Tracy T Smith
Contact
smithtra@musc.edu
8437925164

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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