Dual Use of Cigarettes and E-cigarettes

This randomized clinical trial evaluates the effectiveness of augmented-dose combination nicotine replacement therapy (NRT) versus standard-dose NRT and no-NRT control for cessation of dual combustible cigarette (CC) and electronic cigarette (EC) use. Adults who currently engage in dual use and are motivated to quit both products will be assigned to one of three 12-week interventions: (1) no pharmacotherapy (behavioral support only), (2) standard-dose NRT (21 mg nicotine patch + 4 mg lozenges, 5-20/day), or (3) augmented-dose NRT (21 mg + 14 mg patches + 4 mg lozenges, 5-30/day). All groups receive evidence-based behavioral support through the EX Program. Primary outcomes include biochemically confirmed dual abstinence and CC-only abstinence at 12 and 24 weeks. A subset of participants will provide blood and saliva samples to assess DNA damage biomarkers associated with tobacco use and cessation.

We propose a randomized controlled trial to develop and evaluate a cessation program with two different strategies for dual users during pregnancy. We plan to enroll 45 pregnant mothers (≤20 gestational weeks) with low household incomes from the Western NY region. To be eligible, they must be currently dual using CCs and nicotine-containing ECs. These mothers will be randomized into one of three groups: 1) simultaneous cessation intervention group (N=15), 2) stepwise cessation intervention group (N=15), and 3) control group (N=15). We hypothesize that nicotine abstinence rates at 8 weeks after randomization will be higher in the intervention groups than in the control group.