Tolerability and pharmacokinetics of single and repeated doses of nicotine with The Straw, a novel nicotine replacement product

Abstract

The Straw Nicotine Oral Delivery System is a novel form of nicotine replacement therapy designed to provide not only nicotine but also oral and manual stimulation and ease of dosing. The Straw is a single-use drinking straw containing loose nicotine bitartrate particles that are ingested with the first sip of a beverage. This article describes single- and repeated-dose pharmacokinetics and tolerability of The Straw in a group of 24 smokers. The subjects were randomized to receive 12, 8, or 4 mg nicotine or placebo via The Straw following overnight abstinence from smoking. On one occasion, subjects took only one dose of nicotine; a week later they took eight doses, one every 1.5 hr. The orally ingested nicotine was well tolerated with single and repeated dosing. Plasma levels of nicotine peaked between 1 and 2 hr after a single dose at levels ranging from 6 ng/ml (4-mg dose) to 20 ng/ml (8- and 12-mg doses). Nicotine levels were not different between the 8-mg and 12-mg doses, possibly related to individual variability. Dosing repeatedly with The Straw led to greater nicotine levels that continued to increase with additional dosing. Levels achieved were comparable with or greater than those of other replacement products.