Smoking Reduction
Conditions
Brief summary
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
OTHERMenthol-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.
OTHERTobacco-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.
Sponsors
Nikki Nollen, PhD, MA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who switch from cigarettes to electronic cigarettes at Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of respiratory symptoms using spirometry | Week 12 | 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. |
| Amount of e-liquid consumed | Week 12 | E-liquid consumed will be measured in both groups as a measure of acceptability of menthol versus tobacco e-cigarettes. |
Countries
United States
Contacts
CONTACTTricia Snow
PRINCIPAL_INVESTIGATORNicole Nollen, PhD
University of Kanas Medical Center
Outcome results
None listed