The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Menthol-flavored electronic cigarette, Tobacco-flavored electronic cigarette.
- Who it may be relevant to
- Registry conditions: Smoking Reduction. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from combustible cigarettes to e-cigarettes in adult menthol smokers.
Detailed description
Menthol smokers (n=800), stratified by race, will be randomized 1:1 into a 12-week open label, non-inferiority trial comparing a 4th generation nicotine salt-based pod-system e-cigarette in menthol- versus tobacco-flavored e-liquid. Follow-up will continue through week 26. The primary outcome is rate of switching from combustible cigarettes to e-cigarettes at week 12.
Interventions
- Other Menthol-flavored electronic cigarette
Participants will receive 12 weeks of menthol -flavored electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of the electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes. - Other Tobacco-flavored electronic cigarette
Participants will receive 12 weeks of tobacco-flavored electronic cigarettes to aid in switching from combustible cigarettes. Participants will be instructed on proper use of the electronic cigarettes, educated about electronic cigarettes and participate in motivation enhancement and substituting electronic cigarettes for cigarettes.
Primary outcome measures
- Number of participants who switch from cigarettes to electronic cigarettes at Week 12 [Time frame: Week 12]
Secondary outcome measures (2)
- Assessment of respiratory symptoms using spirometry [Time frame: Week 12]
- Amount of e-liquid consumed [Time frame: Week 12]
Eligibility criteria
Inclusion criteria
- ≥ 21 years of age
- Smoke ≥ 5 cigarettes per day (CPD)
- Smoke menthol cigarettes for ≥ 6 months
- Verified smoker (CO >5ppm)
- Functioning telephone
- Interested in switching to E-cigarettes
Exclusion criteria
- Interested in quitting smoking
- Use of other tobacco products in past 30 days (i.e. cigarillos, cigars, hookah, smokeless tobacco, pipes)
- E-cigarette use on ≥ 4 of the past 30 days
- Uncontrolled hypertension: BP ≥ 180(systolic) or ≥ 105 (diastolic)
- Use of smoking cessation pharmacotherapy in the month prior to enrollment
- Pregnant, contemplating getting pregnant, or breastfeeding
- Plans to move from Kansas City during the treatment and follow-up phase
- Another household member enrolled in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT05555069 · STUDY00148382