DOSE-UP: Dose Optimization for Smoking and E-Cigarette Use Pharmacotherapy

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07754578
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Dual Use of Cigarettes and E-cigarettes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Text- and web-based support — BEHAVIORAL
    Participants will enroll in the Ex Program for support in quitting smoking and vaping.
  • Nicotine Replacement Therapy (NRT, nicotine patch) — DRUG
    21mg patch
  • Nicotine Replacement Therapy (NRT, nicotine patch) — DRUG
    21mg + 14mg patch
  • Nicotine replacement therapy lozenge — DRUG
    4mg; 5-20/day
  • Nicotine replacement therapy lozenge — DRUG
    4mg; 5-30/day

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Oct 10, 2026
Status verified
Aug 2026
Primary completion
Apr 10, 2030
Completion
Jul 10, 2031

Study Design

Enrollment
321 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Behavioral Support
    Participants will receive behavioral support only.
  • Experimental: Standard dose NRT
    Participants will receive a standard dose of nicotine replacement therapy (NRT).
  • Experimental: High dose NRT
    Participants will receive a higher dose of NRT than what is typically used.

Primary Outcome Measure

Dual use abstinence [ Time Frame: Week 12, Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425-

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By research site
Medical University of South Carolina· Charleston, SC

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