A randomised, crossover, clinical study to assess nicotine pharmacokinetics and subjective effects of the BIDI® stick ENDS compared with combustible cigarettes and a comparator ENDS in adult smokers

Fearon, Ian M.; Gilligan, Karin; Seltzer, Ryan; McKinney, William T.

doi:10.1186/s12954-022-00638-0

Cited by 4 publications

(1 citation statement)

References 57 publications

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“…Nicotine gum was used as a reference control as it is generally accepted to be a product with low AL. There is a growing body of research using similar methods to study various types of ENDS 24 , 33 , 34 , including research on cig-a-like products such as Vuse Solo 22 , 23 , 35 .…”

Section: Introductionmentioning

confidence: 99%

Part one: abuse liability of Vuse Solo (G2) electronic nicotine delivery system relative to combustible cigarettes and nicotine gum

Campbell

Jin

Round

et al. 2022

Sci Rep

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Abuse liability (AL) of electronic nicotine delivery systems (ENDS) is relevant as the category increases in popularity as a potentially less-harmful alternative to cigarette smoking. AL assessments are important to the FDA in determining if a new product is appropriate for the protection of public health. This paper reports the results for Vuse Solo (G2 cartridge design) compared to high and low AL-comparators evaluated in an open-label, randomized crossover confinement AL study. The confinement design was adapted from previous ambulatory studies of Vuse Solo (G1 cartridge design) and included product familiarization sessions before each four-hour test session in which subjective measures, nicotine pharmacokinetics (PK), and physiological endpoints were assessed following a single 10-min ad libitum product use session. Product liking, intent to use again, suppression of urge to smoke, and nicotine PK were lower after use of Vuse Solo compared to cigarettes and higher after use of Vuse Solo compared to nicotine gum. No significant differences in blood pressure or heart rate were observed between the products pre- to post-product use. These data reinforce previous research and provide the scientific evidence to support regulatory decisions demonstrating that Vuse Solo has an AL profile lower than that of combustible cigarettes but higher than that of nicotine gum and, therefore, may be a suitable replacement for cigarette smoking for some adult smokers.

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Section: Introductionmentioning

confidence: 99%

Part one: abuse liability of Vuse Solo (G2) electronic nicotine delivery system relative to combustible cigarettes and nicotine gum

Campbell

Jin

Round

et al. 2022

Sci Rep

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Nicotine Delivery of a Menthol-Flavored Heat-not-Burn Tobacco Product During Directed Use

Yingst

Bordner

Hrabovsky

et al. 2023

Nicotine and Tobacco Research

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Introduction IQOS was authorized by the Food and Drug Administration (US FDA) as a modified risk tobacco product (MRTP). We conducted a pharmacokinetic study evaluating the nicotine delivery and subjective effects of IQOS use among current menthol cigarette smokers to better understand if IQOS is an acceptable cigarette alternative in light of the proposed menthol cigarette ban. Methods Participants were adult smokers of >4 menthol cigarettes per day (CPD). After 14-hour nicotine abstinence, participants were provided an IQOS device and menthol heatstick to puff every 20 seconds for a total of 14 puffs. Blood samples were collected at baseline and during active use to calculate nicotine boost from baseline to peak concentration. Nicotine withdrawal symptoms were collected before and after IQOS use. In addition, a modified Product Evaluation Scale for IQOS was collected after use. Results Participants (n=8) were a mean age of 43.9 years, 63% were female, 88% identified as White, and they smoked a mean of 17.1 menthol CPD. After IQOS use, the mean nicotine boost obtained was 15.96 ng/mL (SD=6.91) (range 9.31 to 30.55ng/ml). Most (75%) participants reported enjoying use of the product “a lot” or greater and more than half (62.5%) reported reduced cigarette cravings. Most participants reported no side effects after use, however, 2 experienced dry mouth, 3 experienced dizziness, 1 experienced throat irritation, and 1 experienced headache. Conclusion We found that directed use (14 puffs) of menthol IQOS delivered a mean nicotine boost of 15.96 ng/ml which reduced craving for a cigarette. The majority of participants enjoyed use of IQOS and reported mild side effects. Implications Menthol IQOS delivered a sufficient dose of nicotine perceived as satisfying by menthol cigarette smokers and it reduced craving with mild side effects. Menthol IQOS has potential to serve as a less harmful alternative for menthol cigarette smokers. The availability of modified risk products like IQOS should be considered by FDA's Comprehensive Plan for Tobacco and Nicotine Regulation.

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Assessing Nicotine Pharmacokinetics of New-Generation Tobacco Products and Conventional Cigarettes: A Systematic Review and Meta-analysis

Cao,

Liu,

et al. 2024

Nicotine and Tobacco Research

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Introduction New generation tobacco products (NGPs) hold promises as modified-risk alternatives to conventional cigarettes (CCs), given their comparable characteristics. This study investigated the nicotine pharmacokinetics (PK) of NGPs, encompassing closed pod systems, refillable e-cigarettes (ECs), and heated tobacco products (HTPs), in comparison to CCs through systematic review and meta-analysis. Methods A comprehensive search was conducted on PubMed, Embase, and Web of Science for articles published between January 2013 and July 2023. Maximum nicotine concentration (Cmax), time to the peak concentration (Tmax), and total nicotine exposure (area under the concentration-time curve, AUC) were extracted to evaluate nicotine delivery PK. Random effects meta-analyses were performed to determine pooled standardized mean differences (SMD), facilitating a comparison of PK profiles between NGPs and CCs. Subgroup analyses exploring flavors and nicotine concentrations across NGPs, and CCs were also conducted. Results The meta-analysis incorporated 30 articles with 2728 participants. Cmax and AUC were significantly lower for NGPs, while Tmax demonstrated statistical similarity compared to CCs. Among three NGPs, Cmax and AUC were lower for closed pod systems and refillable ECs. In HTPs, Cmax was statistically similar while AUC was lower compared to CCs. Tmax was statistically similar in closed pod systems and HTPs compared to that of CCs. No significant difference was observed in the comparisons of PK between each type of NGPs versus CCs. Conclusions NGPs delivered less nicotine than CCs but reached Cmax over a similar timeframe, indicating that NGPs may serve as modified-risk alternatives with lower nicotine delivery to CCs for craving relief and smoking cessation. Implication This study suggested that NGPs, such as the closed pod systems, the refillable ECs, and the HTPs, delivered either lower or comparable nicotine levels and achieved peak nicotine concentration at a similar rate as CCs. Our findings carry implications that NGPs can serve as modified-risk nicotine alternative to CCs in helping smokers to manage cravings and potentially quit smoking, thereby highlighting their value in the field of tobacco harm reduction.

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A randomised, crossover, clinical study to assess nicotine pharmacokinetics and subjective effects of the BIDI® stick ENDS compared with combustible cigarettes and a comparator ENDS in adult smokers

Cited by 4 publications

References 57 publications

Part one: abuse liability of Vuse Solo (G2) electronic nicotine delivery system relative to combustible cigarettes and nicotine gum

Part one: abuse liability of Vuse Solo (G2) electronic nicotine delivery system relative to combustible cigarettes and nicotine gum

Nicotine Delivery of a Menthol-Flavored Heat-not-Burn Tobacco Product During Directed Use

Assessing Nicotine Pharmacokinetics of New-Generation Tobacco Products and Conventional Cigarettes: A Systematic Review and Meta-analysis

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