Evidence map›Paper›PMID 26438645›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2016

Comparison of the Pharmacokinetics of Nicotine Following Single and Ad Libitum Use of a Tobacco Heating System or Combustible Cigarettes.

Patrick Picavet, Christelle Haziza, Nicola Lama, Rolf Weitkunat, Frank Lüdicke

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01780688 (A Single-center, Open-label, Randomized, Controlled, Crossover Study to Explore the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System), which is not on this map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01780688 nacompletednot on this map

A Single-center, Open-label, Randomized, Controlled, Crossover Study to Explore the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System (THS) 2.1 Compared to Conventional Cigarettes Following Single and ad Libitum Use in Smoking, But Otherwise Healthy Subjects.

TypeinterventionalSponsorPhilip Morris Products S.A.Ran2012 to 2012Enrolled33ConditionsSmokingArmsConventional cigarettes (CC), THS 2.1
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  9. IQOSInternational journal of environmental research and public health · 2018
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  17. Use of quantitativeFrontiers in toxicology · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Patrick PicavetDepartment of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.
Christelle HazizaDepartment of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.
Nicola LamaDepartment of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.
Rolf WeitkunatDepartment of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland.
Frank LüdickeDepartment of Research and Development, Philip Morris Products S.A., Neuchâtel, Switzerland frank.luedicke@pmi.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe aimed to compare the pharmacokinetics of nicotine between the heat-not-burn Tobacco Heating System 2.1 (THS 2.1) and combustible cigarettes (CCs). We also examined whether the subjective urge to smoke was associated with the pharmacokinetics of nicotine.

methodsThis open-label, randomized, two-period, two-sequence crossover study conducted in 28 healthy smokers assessed the pharmacokinetics of nicotine after single and ad libitum use of the THS 2.1 or CCs. During the 7-day confinement period, blood samples were drawn for pharmacokinetic analysis. Subjective effects related to THS 2.1 or CC use were assessed using the Questionnaire of Smoking Urges (QSU-Brief).

resultsThe nicotine delivery rate was similar with the THS 2.1 and CCs after single and ad libitum use. The time to the maximum nicotine concentration was 8 minutes after single use of the THS 2.1 and CCs. The time to the peak concentration following ad libitum use was similar between the THS 2.1 and CCs. The maximum plasma nicotine concentration after single use of the THS 2.1 was 8.4 ng/mL, 70.3% of that obtained with CCs. A transient reduction from baseline in the urge to smoke of 40% was observed 15 minutes after the single use of both the THS 2.1 and CCs. The mean QSU-Brief total scores following single and ad libitum use were similar for the THS 2.1 and CCs.

conclusionsThese results suggest that the THS 2.1 effectively delivers nicotine and achieves similar pharmacokinetic profiles to CCs. The THS 2.1 also reduced the urge to smoke similarly to CCs. IMPLICATIONS: Reducing exposure to toxicants and safer delivery of nicotine are among the strategies that may reduce the harm of smoking-related diseases. In the present study, we investigated the pharmacokinetics of nicotine and their effects on the urge to smoke using the THS 2.1. It was developed to replicate the ritual of smoking as closely as possible by providing nicotine in a way that mimics CC smoking, but limits pyrolysis and combustion by heating tobacco at a much lower temperature than CCs (heat-not-burn).

Indexed as

NicotineSmokingTobacco ProductsAdultFemaleHumansMaleMiddle AgedYoung AdultNicotine

Identifiers

PMID26438645
PMCPMC4826489

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.