Health TrialsbyHealthPanel

The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers

ConditionSmoking Reduction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNikki Nollen, PhD, MA

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥ 21 years of age

Smoke ≥ 5 cigarettes per day (CPD)

Smoke menthol cigarettes for ≥ 6 months

Verified smoker (CO >5ppm)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Menthol-flavored electronic cigarette

    Other intervention

    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.

  • Tobacco-flavored electronic cigarette

    Other intervention

    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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Menthol Flavor Electronic CigaretteActive comparator 1 intervention
Group B: Tobacco Flavor Electronic CigaretteActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who switch from cigarettes to electronic cigarettes at Week 12

Complete switching is defined as exclusive use of e-cigarettes, confirmed with CO\< 6ppm and predominant switching; defined as use of the e-cigarette with \>50% reduction in CPD. This will compare the effectiveness of menthol versus tobacco e-cigarettes at facilitating switching at Week 12.

Time frame
Week 12

Secondary outcomes

1

Assessment of respiratory symptoms using spirometry

Spirometry summarizing forced expiratory flow (FEF) 25-75% and the American Thoracic Society Questionnaire will assess will assess acute respiratory symptoms experienced by cigarette and electronic cigarette smokers. This will help assess the tobacco harm reduction of electronic cigarettes.

Time frame
Week 12
2

Amount of e-liquid consumed

E-liquid consumed will be measured in both groups as a measure of acceptability of menthol versus tobacco e-cigarettes.

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nikki Nollen, PhD, MA

Lead sponsor

University of Kansas Medical Center

Sponsor institution

Source ClinicalTrials.gov
Apply now