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Part two: an unblinded, parallel, randomized study to assess nicotine pharmacokinetics of four Vuse Solo ENDS flavors in smokers.

ABSTRACT: We report the findings from a randomized, parallel study designed to evaluate nicotine pharmacokinetics (PK) following 10 min of ad libitum use of electronic nicotine delivery system (ENDS) in four flavor variants. Subjects were randomized an investigational product (IP) and blood samples were collected for PK assessments during a test session. Primary endpoints were baseline-adjusted values of maximum plasma nicotine concentration (C_max) and area under the nicotine concentration-vs-time curve up to 60 min (AUC_nic0-60). Baseline-adjusted mean C_max ranged from 6.53 to 8.21 ng/mL, and mean AUC_nic0-60 ranged from 206.87 to 263.52 ng min/mL for all ENDS IPs. Results of geometric mean C_max and AUC_nic0-60 values were within 95% confidence intervals (CI) among the ENDS IP flavor variants tested.

SUBMITTER: Keyser BM

PROVIDER: S-EPMC10235118 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Part two: an unblinded, parallel, randomized study to assess nicotine pharmacokinetics of four Vuse Solo ENDS flavors in smokers.

Keyser Brian M BM Hong Kyung Soo KS DeLuca Patricia P Jin Tao T Jones Bobbette A BA Nelson Paul P Schmidt Eckhardt E Round Elaine K EK

Scientific reports 20230601 1

We report the findings from a randomized, parallel study designed to evaluate nicotine pharmacokinetics (PK) following 10 min of ad libitum use of electronic nicotine delivery system (ENDS) in four flavor variants. Subjects were randomized an investigational product (IP) and blood samples were collected for PK assessments during a test session. Primary endpoints were baseline-adjusted values of maximum plasma nicotine concentration (C<sub>max</sub>) and area under the nicotine concentration-vs-t ...[more]

PMID: 37264061

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Project description:BackgroundNicotine 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.MethodsIn 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.ResultsMean [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.ConclusionsBIDI® 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 registrationClinicalTrials.gov (identifier number NCT05072925).

Project description:IntroductionSwitching to noncombustible tobacco products presents an opportunity for cigarette smokers to potentially reduce the health risks associated with smoking. Electronic Nicotine Delivery Systems (ENDS) are one such product because the vapor produced from ENDS contains far fewer toxicants than cigarette smoke. To investigate the biochemical effects of switching from smoking to an ENDS, we assessed global metabolomic profiles of smokers in a 7-day confinement clinical study.MethodsIn the first 2 days of this clinical study, the subjects used their usual brand of cigarettes and then switched to exclusive ENDS ad libitum use for 5 days. Urine and plasma samples were collected at baseline and 5 days after switching. The samples were analyzed using a mass spectrometry-based metabolomic platform.ResultsRandom forest analyses of urine and plasma metabolomic data revealed excellent predictive accuracy (>97%) of a 30-metabolite signature that can differentiate smokers from 5-day ENDS switchers. In these signatures, most biomarkers are nicotine-derived metabolites or xenobiotics. They were significantly reduced in urine and plasma, suggesting a decreased xenobiotic load on subjects. Our results also show significantly decreased levels of plasma glutathione metabolites after switching, which suggests reduced levels of oxidative stress. In addition, increased urinary and plasma levels of vitamins and antioxidants were identified, suggesting enhanced bioavailability due to discontinuation of cigarette smoking and switching to Vuse ENDS use.ConclusionsOur results suggest reduced toxicant exposure, reduced oxidative stress, and potential beneficial changes in vitamin metabolism within 5 days in smokers switching to Vuse ENDS.ImplicationsSwitching from smoking to exclusive ENDS use in clinical confinement settings results in significant reduction of nicotine metabolites and other cigarette-related xenobiotics in urine and plasma of subjects. Significantly decreased oxidative stress-related metabolites and increased urinary and plasma levels of vitamin metabolites and antioxidants in 5-day short-term ENDS switchers suggest less toxic physiological environment for consumers of ENDS products and potential health benefits if such changes persist.

Dataset Information

Part two: an unblinded, parallel, randomized study to assess nicotine pharmacokinetics of four Vuse Solo ENDS flavors in smokers.

Publications

Part two: an unblinded, parallel, randomized study to assess nicotine pharmacokinetics of four Vuse Solo ENDS flavors in smokers.

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