Augmented Doses of Nicotine Replacement Therapy: Feasibility for Dual Cigarette and E-Cigarette Cessation

Abstract

Introduction

Dual use of combustible cigarettes and e-cigarettes is common and has harmful health effects. Many who dual use want to quit, but there are no empirically supported dual cessation interventions. High-dose nicotine replacement therapy is effective for treating heavy smoking and may be applied to treating dual use of combustible cigarettes and e-cigarettes.

Methods

In this pilot feasibility trial, individuals using both combustible cigarettes and e-cigarettes who wanted to quit were randomly assigned to a 28-day supply of nicotine replacement therapy in one of 3 doses: Standard (21mg patch, qd + 4mg lozenge prn [minimum of 5, up to 20/day]); Mid (21mg patch + 14mg patch + 4mg lozenge [5–30/day]), or High (2 × 21mg patches + 4mg lozenges [5–40/day]). Participants reported combustible cigarette and e-cigarette use daily throughout treatment and 1-month follow-up.

Results

Participants enrolled in the study (N=46 from 2023 to 2024, analyzed 2025) had high nicotine dependence and most completed study procedures. Participants in the Mid group reported using nicotine replacement therapy on more days relative to the other groups. Participants in Mid and High reported numerically higher 7-day point-prevalence dual abstinence at end of treatment (13% for both groups vs 6% Standard) and follow-up (33% for both groups vs 0% Standard). Generaelized estimating equation models showed a significantly higher likelihood of abstinence on a given day for the Mid and High groups relative to Standard (ps<0.05).

Conclusions

Augmented doses of nicotine replacement therapy are a feasible, promising treatment for dual cessation of combustible cigarettes and e-cigarettes. Future research should evaluate this approach in a more rigorous, fully powered trial.

Trial Registration

This study is registered at www.clinicaltrials.gov NCT06087328.