Dataset Information

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.

ABSTRACT:

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 C_{max 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] AUC_0-120 (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 T_max 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 C_{max 0-120}, AUC_0-120, and median T_max 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 C_{max 0-120} and AUC_0-120 but not for T_max 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).

SUBMITTER: Fearon IM

PROVIDER: S-EPMC9160848 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Fearon Ian M IM Gilligan Karin K Seltzer Ryan G N RGN McKinney Willie W

Harm reduction journal 20220602 1

<h4>Background</h4>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<sup>®</sup> Stick is a disposable ENDS product which contains 59 mg/ml nicotine benzoate salt and various flavours.<h4>Methods</h4>In this study, we assessed nicotine pharmacokinetics and subjective effects of 6 flavour variants ...[more]

PMID: 35655314

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Project description:IntroductionThis randomized, open-label, crossover clinical study evaluated nicotine pharmacokinetics (PK) and subjective effects of the JUUL System (JS; Juul Labs, Inc.) with three nicotine concentrations compared to the usual brand (UB) cigarettes in 24 adult smokers.MethodsAt five study visits, subjects used either the JS in 59 mg/mL, JS 18 mg/mL (two visits), and JS 9 mg/mL (all tobacco-flavored) or smoked their UB cigarette first during a controlled puffing sequence (CPS) and then ad libitum (5 min) use sessions. Blood samples were taken at specified timepoints for 60 min in each session. The modified Product Evaluation Scale assessed subjective effects 30-min post-use in the CPS session.ResultsMaximum plasma nicotine concentration (Cmax-BL), total nicotine exposure (AUC0-60-BL), and rate of plasma nicotine rise were significantly lower for all JS products compared to subjects' UB cigarette in CPS and ad libitum use sessions. In both use sessions these PK parameters were significantly higher for JS 59 mg/mL compared to 18 and 9 mg/mL. Subjective measures of cigarette craving relief and "Enough Nicotine" for JS 59 mg/mL did not differ significantly from UB cigarettes, but JS 18 and 9 mg/mL were rated significantly lower than JS 59 mg/mL and UB cigarettes.ConclusionsNicotine exposure and subjective relief were directly related to JS nicotine concentration: higher nicotine concentrations gave rise to significantly greater plasma nicotine levels and relief from craving. Heavier and more dependent smokers may require the greater nicotine delivery of JS 59 mg/mL to successfully transition away from cigarettes.ImplicationsIt has been suggested that electronic nicotine delivery systems (ENDS) and other alternative nicotine delivery products that more closely mimic the nicotine pharmacokinetics (PK) of cigarettes may facilitate smokers transitioning away from cigarettes. We examined nicotine PK and subjective effects of JUUL System (JS) ENDS with three nicotine concentrations (59, 18 and 9 mg/mL) compared to combustible cigarettes. Nicotine delivery from JS ENDS was nicotine concentration dependent, with higher nicotine concentrations giving rise to higher nicotine exposure. These findings suggest that heavier and more dependent smokers may require ENDS with nicotine concentrations greater than 20 mg/mL to successfully transition away from cigarettes.

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Dataset Information

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.

Background

Methods

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

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.

Background

Methods

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

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.