Background Nicotine pharmacokinetic assessments of electronic nicotine delivery systems (ENDS) are crucial to understand their ability to provide an alternative to cigarette smoking. Subjective effects data also strongly contribute to this understanding. The BIDI® Stick is a disposable ENDS product which contains 59 mg/ml nicotine benzoate salt and various flavours. Methods In this study, we assessed nicotine pharmacokinetics and subjective effects of 6 flavour variants of BIDI® Stick ENDS in adult smokers, compared to cigarettes and a comparator ENDS product. During each of eight study visits, 18 volunteer smoker subjects randomly used one of either their usual brand (UB) of cigarette, a BIDI® Stick ENDS, or a comparator ENDS (JUUL 59 mg/ml nicotine with Virginia Tobacco flavour), during both controlled (10 puffs, 30 s apart) and ad libitum (60 min) puffing sessions. Blood samples were collected at various time points and subjective effects questionnaires were administered. Results Mean [SD] plasma nicotine Cmax 0–120 was not significantly different between BIDI® Stick ENDS with any flavour (range 15.3 [9.90] ng/ml for BIDI® Stick Winter to 17.6 [9.00] ng/ml for BIDI® Stick Classic) and UB cigarettes (16.2 [9.17] ng/ml). Mean [SD] AUC0-120 (range 569.7 [327.29] to 628.6 [408.99] min*ng/ml for BIDI® Stick ENDS and 747.1 [325.48] min*ng/ml for UB cigarettes) and median Tmax 0–120 (range 5-7 min for all BIDI® Stick ENDS and UB cigarettes) values were also not significantly different between BIDI® Stick ENDS and UB cigarettes, while subjective effects measures were also similar between BIDI® Stick ENDS and UB cigarettes. Mean [SD] plasma nicotine Cmax 0–120, AUC0-120, and median Tmax 0–120 were 6.8 [4.13] ng/ml, 243.6 [179.04] min*ng/ml, and 5 min, respectively, for JUUL ENDS. These values were significantly different compared with those for all BIDI® Stick ENDS and UB cigarettes for both Cmax 0–120 and AUC0-120 but not for Tmax 0–120. Conclusions BIDI® Stick ENDS delivered nicotine to users comparably to their UB combustible cigarette and higher than JUUL ENDS, and also elicited similar subjective effects such as satisfaction and relief. Thus, the BIDI® Stick ENDS may be a satisfying alternative to cigarettes among current smokers and may support their transitioning away from cigarette smoking. Trial registration ClinicalTrials.gov (identifier number NCT05072925).
Inaccurate labels on some e-cigarette products have prompted calls for routine testing to monitor product label integrity. The objective of this study was to compare label statements of commercial disposable/non-chargeable e-cigarette products for nicotine concentration and e-liquid volume with analytically verified levels. Commercial e-cigarette samples were analyzed for nicotine concentration (N = 51), e-liquid volume and total nicotine content (N = 39). Twenty-three of the 51 samples analyzed for nicotine deviated from their label statements by more than ± 10%. Deviations ranged from -50.1% to + 13.9%. Thirty of the 39 samples analyzed for e-liquid volume deviated from their label statements by more than ± 10%. Deviations ranged from -62.1% to + 13.3%. Only one brand listed total nicotine on the label. In thirty-one of the 39 samples, calculated total nicotine amount in e-liquid deviated from the amounts calculated from the label metrics by more than ± 10%. Deviations ranged from -66.8% to -1.43%. These findings underscore the need for regulatory enforcement of manufacturing quality control and product labeling practices to optimize the harm reduction potential and consumer experience associated with the use of e-cigarette products.
Background: Nicotine pharmacokinetic assessments of electronic nicotine delivery systems (ENDS) are crucial to understand their ability to provide an alternative to cigarette smoking. Subjective effects data also strongly contribute to this understanding. The BIDI® Stick is a disposable ENDS product which contains 6% nicotine benzoate salt and various flavours. Methods: In this study we assessed nicotine pharmacokinetic and subjective effects of BIDI® Stick ENDS in adult smokers, compared to cigarettes and a comparator ENDS product. During each of eight (8) study visits, volunteer smoker subjects randomly used one of either their usual brand (UB) of cigarette, a BIDI® Stick ENDS, or a comparator ENDS (JUUL 5% with Virginia Tobacco flavour), during both defined (10 puffs, 30 seconds apart) and ad libitum puffing sessions. Blood samples were collected at various time points and subjective effects questionnaires were administered. Results: Plasma nicotine Cmax 0-120 was not significantly different between BIDI® Stick ENDS with any flavour (range 15.3 (9.90) ng/ml for BIDI® Stick Winter to 17.6 (9.00) ng/ml for BIDI® Stick Classic) and UB cigarettes [16.2 (9.17) ng/ml]. AUC0-120 and Tmax 0-120 values were also not significantly different between BIDI® Stick ENDS and UB cigarettes, while subjective effects measures were also similar between BIDI® Stick ENDS and UB cigarettes. Conclusions: BIDI® Stick ENDS delivered nicotine to users comparably to their UB combustible cigarette and also elicited similar subjective effects such as satisfaction and relief. Thus, the BIDI® Stick ENDS may be a satisfying alternative to cigarettes among current smokers and may support their transitioning away from cigarette smoking. Trial registration: ClinicalTrials.gov (identifier number NCT05072925).
BACKGROUND This is the first study of perceptions, intentions, actual use, and quitting behaviors among adult users and nonusers of LUCY® Chew and Park, a recreational nicotine gum product that is not a nicotine replacement therapy (NRT). METHODS Data were collected from a Qualtrics online panel (N = 1,000) of non-users recruited based on smoking status, and from current and former LUCY users (N = 500). In addition to descriptive cross-sectional analyses, logistic regression was used to estimate the probability of intent to try and of product appeal among groups of different smoking status. RESULTS Among non-users, smokers with and without intentions to quit showed high intention to try LUCY (odds ratios 15.6 [95% CI 9.3, 27.6] and 9.8 [95% CI 5.8, 17.3] respectively compared to former smokers), and never-smokers showed low intention to try. Most former and never-smokers did not find any of the three LUCY flavors appealing; there was no evidence that flavors appealed more to young adults than to older adults. Never-smokers perceived far greater health risks from LUCY use compared to smokers. Among product users, two-thirds (61.6%) had vaped regularly, and half (49.8%) had smoked cigarettes regularly before initiating use; 43.4% of the latter indicated they began use “to help me quit smoking.” Only 0.6% of young adult users (aged 21–30) had not used tobacco products previously. Half of the user sample had previously used NRT gum; flavors and taste were the most-mentioned difference. One-third of current users who had smoked regularly prior to using LUCY said they would return to smoking if LUCY were not available. CONCLUSIONS LUCY does not appear to attract tobacco nonusers; results for young adults suggest minimal appeal to youth. LUCY was used primarily by male and female smokers and vapers wishing to quit or reduce use of those products; many found NRT gum an unappealing alternative due to taste and/or product image. LUCY flavors seem to enhance appeal to tobacco users, whereas never-smokers viewed LUCY as unappealing and a health risk. These results suggest that a non-NRT nicotine gum may help some users of higher-risk nicotine products reduce or quit use of those products.
INTRODUCTION: Nicotine pharmacokinetic (PK) assessments of electronic nicotine delivery systems (ENDS) are crucial to understand their ability to provide an alternative to cigarette smoking. Subjective effects data also strongly contribute to this understanding. The BIDI® Stick is a disposable ENDS product which contains 6% nicotine benzoate salt and various flavours. METHODS: In this study we assessed nicotine PK and subjective effects of BIDI® Stick ENDS in adult smokers, compared to cigarettes and a comparator ENDS product. During each of eight (8) study visits, volunteer smoker subjects randomly used one of either their usual brand (UB) of cigarette, a BIDI® Stick ENDS, or a comparator ENDS (JUUL 5% with Virginia Tobacco flavour), during both a 4.5-minute defined (10 puffs, 30 seconds apart) and an _ad libitum _puffing session. Blood samples were collected at various time points and subjective effects questionnaires were administered. RESULTS: Plasma nicotine Cmax 0‑120 was not significantly different between BIDI® Stick ENDS with any flavour (range 15.3 (9.90) ng/ml for BIDI® Stick Winter to 17.6 (9.00) ng/ml for BIDI® Stick Classic) and UB cigarettes [16.2 (9.17) ng/ml]. AUC0-120 and Tmax 0‑120 values were also not significantly different between BIDI® Stick ENDS and UB cigarettes, while subjective effects measures were also similar between BIDI® Stick ENDS and UB cigarettes. CONCLUSIONS: BIDI® Stick ENDS delivered nicotine to users comparably to their UB cigarette and also elicited similar subjective effects such as satisfaction and relief. Thus, the BIDI® Stick ENDS may be a satisfying alternative to cigarettes among current smokers and may support their transitioning away from cigarette smoking.
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