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Novel rapid-acting sublingual nicotine tablet as a cigarette substitution strategy.

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Title: Novel rapid-acting sublingual nicotine tablet as a cigarette substitution strategy.
Authors: Rose, Jed E. (AUTHOR), Behm, Frederique M. (AUTHOR), Botts, Tanaia L. (AUTHOR), Botts, David R. (AUTHOR), Willette, Perry N. (AUTHOR), Vocci, Frank (AUTHOR), McCarty, John (AUTHOR)
Source: Psychopharmacology. Sep2022, Vol. 239 Issue 9, p2853-2862. 10p. 2 Charts, 3 Graphs.
Subjects: Nicotine, United States. Food & Drug Administration, Nicotine replacement therapy, Cigarettes, Smoking cessation, Smoking, Harm reduction
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. [ABSTRACT FROM AUTHOR]
Copyright of Psychopharmacology is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Novel rapid-acting sublingual nicotine tablet as a cigarette substitution strategy.
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  Data: <searchLink fieldCode="AR" term="%22Rose%2C+Jed+E%2E%22">Rose, Jed E.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Behm%2C+Frederique+M%2E%22">Behm, Frederique M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Botts%2C+Tanaia+L%2E%22">Botts, Tanaia L.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Botts%2C+David+R%2E%22">Botts, David R.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Willette%2C+Perry+N%2E%22">Willette, Perry N.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Vocci%2C+Frank%22">Vocci, Frank</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22McCarty%2C+John%22">McCarty, John</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Psychopharmacology%22">Psychopharmacology</searchLink>. Sep2022, Vol. 239 Issue 9, p2853-2862. 10p. 2 Charts, 3 Graphs.
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  Data: <searchLink fieldCode="DE" term="%22Nicotine%22">Nicotine</searchLink><br /><searchLink fieldCode="DE" term="%22United+States%2E+Food+%26+Drug+Administration%22">United States. Food & Drug Administration</searchLink><br /><searchLink fieldCode="DE" term="%22Nicotine+replacement+therapy%22">Nicotine replacement therapy</searchLink><br /><searchLink fieldCode="DE" term="%22Cigarettes%22">Cigarettes</searchLink><br /><searchLink fieldCode="DE" term="%22Smoking+cessation%22">Smoking cessation</searchLink><br /><searchLink fieldCode="DE" term="%22Smoking%22">Smoking</searchLink><br /><searchLink fieldCode="DE" term="%22Harm+reduction%22">Harm reduction</searchLink>
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  Data: 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. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Psychopharmacology is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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              Text: Sep2022
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