Grant Number:	1R01CA299937-01A1 Interpret this number
Primary Investigator:	Palmer, Amanda
Organization:	Medical University Of South Carolina
Project Title:	Augmented Doses of Nicotine Replacement Therapy for Quitting Cigarettes and E-Cigarettes
Fiscal Year:	2026

PROJECT SUMMARY Many individuals who smoke combustible cigarettes (CC) turn to e-cigarettes (EC) as a cessation tool, or initiate EC use for a variety of other reasons. However, this may lead to dual use of both EC and CC: Data from population-level surveys as well as clinical trials estimate >30-40% of people who use EC also smoke. Dual use increases exposure to carcinogens and negative health effects of tobacco, including DNA damage, and may have other undesirable consequences. Most people (>56%) who dual use ECs and CCs intend to quit, but only ~25% attempt to quit each year. Whereas a large body of research exists on CC cessation, there is limited information for EC cessation and very little evidence regarding dual use cessation. This gap indicates a substantial need to develop and test interventions for individuals who use EC and CC and want to quit both. Dual use cessation may be particularly challenging due to high nicotine dependence and less confidence in quitting. Nicotine replacement therapy (NRT) has solid evidence for CC cessation and emerging support for EC cessation. Importantly, augmented (high) doses of NRT are indicated for treating heavy smoking and high nicotine dependence. Given that it is a highly accessible, safe, over-the-counter pharmacologic treatment, NRT could be promising for dual use cessation. Our pilot data suggest that the standard dose of NRT for dual cessation may not be as effective as it is for smoking cessation. However, our pilot study findings do support the use of a higher, augmented dose of NRT to promote complete cessation from both CC and EC (standard dose quit rate: 0% vs augmented dose quit rate 33.3%). The proposed application will address the critical need for dual use cessation treatments through a fully-powered 3-arm clinical trial in which participants who use both EC and CC will be randomized to receive behavioral support (EX Program) alongside: A) no pharmacotherapy (NONE); B) a standard dose of NRT (STAN; 21mg patch + 4mg lozenges, 5-20/day); or C) an augmented dose of NRT (AUG; 21mg + 14mg patch + 4mg lozenges, 5-30/day). Participants will complete assessments over 12 weeks, in addition to a 3-month follow-up, to evaluate the efficacy of augmented doses of NRT relative to standard dose or no NRT on 1) dual cessation; and 2) quitting CC but continuing EC use. A subset of participants will provide biospecimen samples to assess changes in biomarkers of tobacco exposure and DNA damage, which may provide insight into cancer risk reduction following dual cessation. Results from this study will substantially advance cancer prevention and tobacco treatment science by providing urgently needed evidence for a scalable, pragmatic intervention for dual EC and CC cessation, which can help to shape clinical practice guidelines. The evaluation of cancer risk biomarkers will elucidate effects on human health, and the study’s findings will help to ease the burden of cancer in the US.





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