A Randomised Study to Investigate the Nicotine Pharmacokinetics of Oral Nicotine Pouches and a Combustible Cigarette

Abstract

Background and Objectives Nicotine pouches (NPs) are a relatively new type of oral smokeless tobacco-free nicotine product. Currently, few data are available on the nicotine pharmacokinetics or subjective effects of NP use. The objective of this study was to determine and compare the pharmacokinetics of nicotine absorption into the blood from different NP variants and a combustible cigarette. Methods In a randomised, controlled, crossover clinical study, nicotine pharmacokinetics and subjective effects were compared among commercially available NPs (five different brands; 6-10 mg nicotine/pouch) and a combustible cigarette. During an 8-day confinement period, 35 healthy adult participants who were current dual users of snus and combustible cigarettes used one study product each day for a defined period following overnight nicotine abstinence. Results Nicotine maximum plasma concentration (C max ) and area under the plasma concentration-time curve between 0 and 6 h (AUC 0-6h ) were significantly greater for the Lyft 10 mg NP than for the cigarette (both p < 0.0001), while the other NPs had C max and AUC 0-6h values that were either greater than or similar to those of the cigarette. Plasma nicotine concentration was not associated with the nicotine contents of the NPs. Time to reach maximum plasma concentration (T max ) was higher for all NPs (60-65 min) than for the cigarette (7 min). Regarding subjective effects, liking and intent to use product again scores were higher for the cigarette than for any NP and were lowest for the NP with the lowest nicotine content. Conclusions This study provides important insight into nicotine pharmacokinetics and subjective effects during NP use, and demonstrates that NPs can provide nicotine in amounts sufficient to replicate cigarette smokers' nicotine uptake following a switch from conventional cigarettes to these potentially less harmful NP products. Further studies are required to ascertain how physical characteristics of NPs other than nicotine content may affect nicotine delivery, pharmacokinetics and subjective responses. ISRCTN Clinical Trial Registry ISRCTN17828518.

Randomized trials assessing the impact of flavors on pharmacokinetic, pharmacodynamic, and subjective parameters in dry and moist nicotine pouch products

“…Thus, it is di cult to draw parallels to other clinical studies with different experimental setup, or actual use. A study utilizing the same usage time and dry and moist NPs with labeled nicotine strengths of 6-10 mg, found similar C max concentrations to our study (11.9-18.4 ng/mL) [17]. The study conditions used herein, where use of one pouch for 60 min is followed by ve hours of abstinence, are unlikely to re ect consumers actual usage patterns.…”

“…A study determining the PK-pro les of NPs from several different manufacturers showed that the nicotine content of a NP gives little information on its nicotine delivery in terms of C max and AUC 0-6h [17]. In line with these ndings, the two product types studied herein contained 9 mg (NP moist varieties) and 6 mg (NP dry varieties) nicotine and showed similar values for C max and AUC inf .…”

Smoking cessation aids and strategies: a population-based survey of former and current smokers in Norway

“…The mechanisms behind the strong association between snus and successful quits are not well understood. The nicotine content and duration of use of snus may provide nicotine in an amount that is similar to cigarette smoking, avoiding or reducing nicotine withdrawal symptoms when quitting cigarettes [41]. There may also be social and cultural expectations towards the use of snus that help fill the gap from the habit of smoking.…”

Biomarkers of Exposure and Potential Harm in Exclusive Users of Nicotine Pouches and Current, Former, and Never Smokers: Protocol for a Cross-sectional Clinical Study

“…Recent surveys of retail sales [17] and product use [16] show that NPs are gaining popularity in the United States, and some authors have suggested that they may form part of a THR approach [23]. To date, however, there are few data available on these relatively new products [14,15,21,22,[73][74][75][76][77][78].…”