Abstract
Rationale
Current nicotine replacement products provide a much slower onset of nicotine delivery than cigarettes, and hence are only marginally effective at supplanting cigarette smoking. Therefore, more effective forms of nicotine replacement are needed.
Objectives
This initial investigation characterized the pharmacokinetic (PK) and subjective effects of a novel sublingual (SL) nicotine tablet designed to deliver nicotine more rapidly to the bloodstream of smokers.
Methods
Study 1 (N = 6) characterized the pharmacokinetics of a 2 mg nicotine SL tablet in comparison to an FDA-approved, marketed 2 mg nicotine lozenge. Study 2 (N = 24) assessed subjective responses of smokers to a single use of a 1 mg and 2 mg SL tablet.
Results
Study 1 found that the time to maximum blood nicotine concentrations was significantly shorter for the SL tablet (14 min) than for the lozenge (82 min), and the initial rate of nicotine absorption was higher (0.4 ng/mL*min vs. 0.0 ng/mL*min), supporting the hypothesis that the SL tablet delivered nicotine more rapidly. Study 2 found that participants reported immediate relief of nicotine withdrawal symptoms after tablet administration, and craving reduction after the 2 mg tablet approached the degree reported for their usual brands of cigarettes (4.2 vs. 4.6 on a 7-point scale). Other subjective responses showed the tablet to be an appealing alternative to smoking.
Conclusions
The novel SL tablet studied shows promise as a nicotine substitution strategy for tobacco harm reduction and smoking cessation treatment. Additional studies are warranted to further investigate the potential of this new approach.
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Funding
Study 1 was funded by the National Institute of Health via a National Institute on Drug Abuse STTR Grant 1R41DA033710-01A1, and Study 2 was funded by Nicotine BRST LLC.
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JER and FMB disclose research support from Foundation for a Smoke-Free World, Philip Morris International, Altria, Embera Neurotherapeutics, Inc., Otsuka Pharmaceutical, JUUL Labs, consulting with Revive pharmaceuticals, and consulting and patent purchase agreement with Philip Morris International.
JM is Nicotine BRST’s Chief Scientific Officer at which he holds an equity interest.
FV has consulted with Revive Therapeutics.
TLB, DRB, and PNW disclose research support from Foundation for a Smoke-Free World, Philip Morris International, Altria, Embera Neurotherapeutics, Inc., Otsuka Pharmaceutical, and JUUL Labs.
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Rose, J.E., Behm, F.M., Botts, T.L. et al. Novel rapid-acting sublingual nicotine tablet as a cigarette substitution strategy. Psychopharmacology 239, 2853–2862 (2022). https://doi.org/10.1007/s00213-022-06171-z
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DOI: https://doi.org/10.1007/s00213-022-06171-z