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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
321
Participants will enroll in the Ex Program for support in quitting smoking and vaping.
21mg patch
21mg + 14mg patch
4mg; 5-20/day
4mg; 5-30/day
Medical University of South Carolina
Charleston, South Carolina, United States
Dual use abstinence
7-day point prevalence biochemically-confirmed abstinence from both e-cigarettes and cigarettes. E-cigarette abstinence is based on self-report and cotinine (if no longer using NRT) and cigarette abstinence is based on self-report and verified with carbon monoxide (CO) confirmation. Non-responders and missing data will be coded as not abstinent.
Time frame: Week 12, Week 24
Cigarette abstinence
7-day point prevalence biochemically-confirmed abstinence from cigarettes (and still using e-cigarettes). Cigarette abstinence is based on self-report and verified with carbon monoxide (CO) confirmation. Non-responders and missing data will be coded as not abstinent.
Time frame: Weeks 12, Week 24
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