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Dual Use of Cigarettes and E-cigarettesAddictionDigital healthMental healthBehavioralBehavioralDrugPhase 2

What this study is

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.

What's being tested

  • Text- and web-based support

    Intervention · BEHAVIORAL

    Participants will enroll in the Ex Program for support in quitting smoking and vaping.

  • Nicotine Replacement Therapy (NRT, nicotine patch)

    Intervention · DRUG

    21mg patch

  • Nicotine Replacement Therapy (NRT, nicotine patch)

    Intervention · DRUG

    21mg + 14mg patch

  • Nicotine replacement therapy lozenge

    Intervention · DRUG

    4mg; 5-20/day

  • Nicotine replacement therapy lozenge

    Intervention · DRUG

    4mg; 5-30/day

Study details

Official title
High-Dose Nicotine Replacement Therapy for Quitting Cigarettes and E-cigarettes
Sponsor
Medical University of South Carolina
Conditions
Dual Use of Cigarettes and E-cigarettes
Enrolling
321 people
Starts
2026-11-01
Est. completion
2031-07-10
Design
Open-label, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗