JAMA network open · 2026
Toxicant Exposures After Switching From Cigarettes to a Pod-Based Electronic Cigarette: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Yingst Jessica M, Krebs Nicolle M, Dahal Sitasnu, Allen Sophia I, Livelsberger Craig, Peters Vicki, Salkin Allison, Bordner Candace, Mazhar Laraib, Reinhart Lisa, Trushin Neil, Zimmerman Courtney, Hassan Kavitha, Bitzer Zachary, Sciamanna Christopher, Zhu Junjia, Foulds Jonathan
Аннотация
IMPORTANCE: Electronic cigarettes (EC) have been shown to expose users to fewer tobacco-related toxicants compared with combustible cigarettes. The current generation of ECs has rapidly shifted toward pod-based nicotine salt formulation ECs, and more research is needed to understand the impacts of using these EC products among those who smoke.
OBJECTIVE: To determine the short-term effects of switching from cigarettes to a pod-based 5% nicotine EC, compared with a 0% nicotine EC.
DESIGN, SETTING, AND PARTICIPANTS: This double-blind, parallel-arm, randomized, placebo-controlled trial with follow-up at 6 weeks (randomized phase) and 10 weeks (postrandomized phase) was conducted at a single-site academic medical center in Pennsylvania from April 22, 2022, to December 12, 2023. Participants included adults who smoked more than 4 cigarettes per day (CPD) and expressed interest in switching completely to an EC. Data were analyzed from August 23, 2024, to December 1, 2025.
INTERVENTIONS: Participants were allocated 1:1 to the standardized research EC (SREC) with 5% nicotine or 0% nicotine for 6 weeks.
MAIN OUTCOMES AND MEASURES: The primary outcome was concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in urine corrected for creatinine level at 6 weeks. Secondary outcomes included exhaled carbon monoxide (CO), cotinine level, CPD, CO-verified cigarette abstinence, and levels of volatile organic compounds.
RESULTS: A total of 104 participants (52 per group) were randomized, of whom 68 (65.4%) were female, with a mean (SD) age of 50.9 (10.0) years. At 6 weeks, the 5% SREC group did not have significantly lower NNAL levels (mean difference [MD], -116.6 [95% CI, -245.4 to 12.2] pg/mg; P = .08). However, a greater proportion of participants in the 5% SREC group were abstinent from cigarettes (19 of 52 [36.5%] vs 6 of 52 [11.5%]; P = .005), compared with the 0% SREC group. The 5% SREC group had greater cotinine levels (MD, 2367.8 [95% CI, 407.5-4328.2] ng/mg; P = .02); however, there were no differences in CPD (MD, -0.9 [95% CI, -3.9 to 2.1] CPD; P = .55) or exhaled CO levels (MD, -5.1 [95% CI, -12.9 to 2.6] ppm; P = .19) between groups. Levels of cyanoethyl mercapturic acid (CYMA) (MD, -49.0 [95% CI, -90.4 to -7.6] ng/mg; P = .02) and 3-hydroxypropyl mercapturic acid (3HPMA) (MD, -290.8 [95% CI, -514.0 to -67.6] ng/mg; P = .01), biomarkers of acrylonitrile (a carcinogen) and acrolein (a cardiac toxicant) exposure (both of which are respiratory toxicants), were lower in the 5% SREC group compared with the 0% SREC group.
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of adults who smoke, switching from cigarettes to a 5% SREC vs a 0% SREC resulted in reduced exposure to some toxicants delivered by cigarette smoking and an increased rate of smoking cessation. ECs that deliver nicotine like a cigarette may have an important role in reducing the harmful toxicant exposure caused by cigarette smoking.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03625986.
OBJECTIVE: To determine the short-term effects of switching from cigarettes to a pod-based 5% nicotine EC, compared with a 0% nicotine EC.
DESIGN, SETTING, AND PARTICIPANTS: This double-blind, parallel-arm, randomized, placebo-controlled trial with follow-up at 6 weeks (randomized phase) and 10 weeks (postrandomized phase) was conducted at a single-site academic medical center in Pennsylvania from April 22, 2022, to December 12, 2023. Participants included adults who smoked more than 4 cigarettes per day (CPD) and expressed interest in switching completely to an EC. Data were analyzed from August 23, 2024, to December 1, 2025.
INTERVENTIONS: Participants were allocated 1:1 to the standardized research EC (SREC) with 5% nicotine or 0% nicotine for 6 weeks.
MAIN OUTCOMES AND MEASURES: The primary outcome was concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in urine corrected for creatinine level at 6 weeks. Secondary outcomes included exhaled carbon monoxide (CO), cotinine level, CPD, CO-verified cigarette abstinence, and levels of volatile organic compounds.
RESULTS: A total of 104 participants (52 per group) were randomized, of whom 68 (65.4%) were female, with a mean (SD) age of 50.9 (10.0) years. At 6 weeks, the 5% SREC group did not have significantly lower NNAL levels (mean difference [MD], -116.6 [95% CI, -245.4 to 12.2] pg/mg; P = .08). However, a greater proportion of participants in the 5% SREC group were abstinent from cigarettes (19 of 52 [36.5%] vs 6 of 52 [11.5%]; P = .005), compared with the 0% SREC group. The 5% SREC group had greater cotinine levels (MD, 2367.8 [95% CI, 407.5-4328.2] ng/mg; P = .02); however, there were no differences in CPD (MD, -0.9 [95% CI, -3.9 to 2.1] CPD; P = .55) or exhaled CO levels (MD, -5.1 [95% CI, -12.9 to 2.6] ppm; P = .19) between groups. Levels of cyanoethyl mercapturic acid (CYMA) (MD, -49.0 [95% CI, -90.4 to -7.6] ng/mg; P = .02) and 3-hydroxypropyl mercapturic acid (3HPMA) (MD, -290.8 [95% CI, -514.0 to -67.6] ng/mg; P = .01), biomarkers of acrylonitrile (a carcinogen) and acrolein (a cardiac toxicant) exposure (both of which are respiratory toxicants), were lower in the 5% SREC group compared with the 0% SREC group.
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of adults who smoke, switching from cigarettes to a 5% SREC vs a 0% SREC resulted in reduced exposure to some toxicants delivered by cigarette smoking and an increased rate of smoking cessation. ECs that deliver nicotine like a cigarette may have an important role in reducing the harmful toxicant exposure caused by cigarette smoking.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03625986.