ArticleFrontiers in pharmacology2026
Assessment of nicotine pharmacokinetics and abuse liability in randomized, crossover studies of Vuse Alto electronic nicotine delivery systems.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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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.
CSD201201: A Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Electronic Nicotine Delivery System P12
CSD201202: A Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12
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12 authors.
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Abstract
Introduction: Understanding the neuropharmacological effects and abuse liability (AL) of electronic nicotine delivery systems (ENDS) is essential for evaluating their potential role in tobacco harm reduction (THR). Nicotine delivered via ENDS engages central nervous system (CNS) pathways involved in reinforcement, craving, and dependence. This research characterized nicotine pharmacokinetics (PK) and AL of Vuse Alto ENDS across multiple nicotine concentrations and flavor and contextualized these findings relative to combustible cigarettes and nicotine replacement therapy (NRT) gum. Methods: Two randomized, open-label, crossover clinical studies were conducted under controlled human-use conditions. Study 1 evaluated eight Vuse Alto ENDS flavors containing 1.5% nicotine, with sequential plasma sampling over 240 min following product use. Study 2 assessed four Vuse Alto ENDS (1.5%-5% nicotine) and incorporated validated subjective effect assessments and PK sampling, alongside participants' usual brand cigarettes and NRT gum. Adult smokers and dual users were enrolled under strict eligibility criteria to ensure participant safety and data integrity. Results: All Vuse Alto variants demonstrated rapid systemic nicotine uptake, with PK profiles consistent across flavors, indicating flavor-independent nicotine delivery. Observed C Discussion: Findings demonstrate that Vuse Alto ENDS deliver nicotine more slowly and at lower levels than cigarettes, reflecting a lower AL while maintaining sufficient CNS-relevant nicotine exposure to potentially support transitions away from smoking. Flavor did not materially influence PK or AL outcomes. Collectively, the results indicate an intermediate neuropharmacological profile consistent with reduced dependence potential and support the potential utility of Vuse Alto ENDS within THR strategies.The clinical studies were registered at ClinicalTrials.gov; NCT05239884 and NCT05210699.
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