This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms.
Able to communicate fluently in English (i.e. speaking, writing, and reading)
Male and female smokers who are > 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.
Have a carbon monoxide (CO) greater than 10 ppm.
Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Regular e-cigarette and nicotine pouch use is defined as greater than 5 days/past 30 days.
Current enrollment or plans to enroll in a smoking cessation program over the duration of the study.
Current use of smoking cessation medication
Provide a CO breath test reading less than 10 ppm at Intake.
Parallel
E-cigarettes
Other interventionParticipants randomized to ECIGS are instructed to switch from smoking combustible cigarettes to using e-cigarettes for 6 weeks. They will be provided with an e-cigarette device and nicotine pods.
Oral nicotine pouches
Other interventionParticipants randomized to ONPS are instructed to switch from smoking combustible cigarettes to using nicotine pouches for 6 weeks. They will be provided with nicotine pouches.
Cigarette Consumption
The primary outcome is the longitudinal daily count of cigarettes from baseline to the end of the switch phase. Daily cigarette consumption will be determined by counting the daily spent cigarette filters returned for each of the 42 days (days 8 - 49).
Cigarette Smoking Across Follow-Up
Average cigarettes per day at the 6-month follow-up is a secondary endpoint, measured by the valid and reliable timeline follow-back (TLFB) interview.
Biomarkers of Exposure: Carbon Monoxide (CO)
Carbon Monoxide (CO) will be measured using a CO monitor. A CO \> 5 ppm indicates combustible cigarette smoking.
Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%)
The mean mid-expiratory forced expiratory flow (FEF25% - 75%) is a measure of lung function and inflammation. FEF25% - 75% will be assessed using spirometry according to the American Thoracic Guidelines.
Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) is a primary nitrosamine marker of tobacco exposure and an often-used indicator of carcinogen exposure. NNAL will be measured in urine and assessed through Liquid Chromatography-Tandem Mass Spectrometry per milligram creatinine (LC-MS/MS per mg creatinine).
Biomarkers of Exposure:1-hydroxypyrene (1-HOP)
1-hydroxypyrene (1-HOP) is a widely used biomarker of carcinogenic polycyclic aromatic hydrocarbon exposure. 1-HOP will be measured in urine and assessed through Liquid Chromatography-Tandem Mass Spectrometry per milligram creatinine (LC-MS/MS per mg creatinine).
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Abramson Cancer Center at Penn Medicine
Lead sponsor
University of Pennsylvania
Sponsor institution
National Cancer Institute (NCI)
Collaborator
University of Pennsylvania
Collaborator
