Not Yet RecruitingPhase 2

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

United States321 participantsStarted 2026-10-10

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age 18+; * report nicotine-containing e-cigarette use 5+ times per day, \>5 days per week, for \> 6 months; * smoking \>1 cigarette per day, \>5 days per week, for \>6 months; * interest in quitting cigarettes and e-cigarettes within the next month (\>6 on 10-point scale); * willing to try nicotine replacement therapy; * access to text/internet/email. Exclusion Criteria: * report use of other tobacco or nicotine products (i.e., pouches, smokeless tobacco, hookah) \>1 time per week in the past 3 months; * have medical contraindications for nicotine replacement therapy use (patch and lozenge; e.g., recent myocardial infarction, arrhythmias, angina, vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated such as PKU); * report current use of smoking cessation medications (varenicline, bupropion, other nicotine replacement therapies); * endorse symptoms of Cannabis Use Disorder (using the CUDIT assessment); * unable to consent (e.g., cognitive deficit, non-English speaking); * live outside the US.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dual use abstinence

Timeframe: Week 12, Week 24

Cigarette abstinence

Timeframe: Weeks 12, Week 24

Trial details

NCT IDNCT07754578

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-04-10

Contact for this trial

Rachel Program Coordinator

(843)737-1516 chrisrac@musc.edu

View on ClinicalTrials.gov More Dual Use of Cigarettes and E-cigarettes trials