Abstract
Rationale
on!® nicotine pouches (NPs) are oral tobacco-derived nicotine products that are tobacco-leaf free and are available in a variety of flavors and nicotine strengths. Switching completely to NPs from cigarettes may present the potential to reduce harm in adult smokers (AS) unable or unwilling to quit smoking. We characterized the abuse potential of six different flavor variants of NPs compared to cigarettes.
Objectives
The objective of this study was to evaluate the nicotine pharmacokinetics (PK) and subjective effects of different flavor variants of NPs compared to participants’ own brand cigarettes (OBCs) in AS.
Methods
In this single-blind, randomized, 7-way crossover study, we assessed nicotine PK, subjective measures (using well-established questionnaires), and product use behavior associated with six flavors of 4 mg NPs and OBCs in AS that remained in clinic for the duration of the test period.
Results
Nicotine Cmax values ranged from 9.0 to 11.5 ng/mL for the NPs and 16.3 ng/mL for OBCs. The tmax ranged from 30.1 to 34.9 min for ONPs and 7.5 min for OBCs. Use of NPs resulted in lower ratings of urge to smoke or craving a cigarette. All the NPs were considered pleasant, but not as much as OBCs. Flavor did not appear to influence the nicotine PK or subjective responses.
Conclusions
Based on the nicotine PK parameters and subjective responses, we conclude that NPs, regardless of flavor, likely have lower abuse potential than cigarettes. Overall, this study suggests that the NPs may be potentially acceptable switching products for adult smokers.
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Acknowledgements
Scientific writing support was provided by Meghan L Thompson, PharmD, PhD and Cynthia S Cecil, both of Altria Client Services LLC.
Funding
This study was funded by Altria Client Services LLC. Authors JR, JL, JW, AV, JE, and MS are employees of Altria Client Services LLC.
The Advarra Institutional Review Board (IRB) (Columbia, MD) reviewed and approved this study. The study was conducted in accordance with Food and Drug Administration (FDA) regulations as described in the Code of Federal Regulations (CFR) 21 Parts 50 and 56, Department of Health and Human Services regulations as described in 45 CFR 46, guidelines resulting from the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP), the European Union (EU) directive 2001/20/EC, and the ethical principles set forth in the Declaration of Helsinki. In addition, the IRB operates in compliance with the portions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule) that apply to research, as described in 45 CFR Parts 160 and 164. All participants in this study reviewed, signed, and dated the informed consent form prior to study initiation.
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Rensch, J., Liu, J., Wang, J. et al. Nicotine pharmacokinetics and subjective response among adult smokers using different flavors of on!® nicotine pouches compared to combustible cigarettes. Psychopharmacology 238, 3325–3334 (2021). https://doi.org/10.1007/s00213-021-05948-y
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DOI: https://doi.org/10.1007/s00213-021-05948-y