← Back to all trials
Not Yet Recruiting
NCT07754578
DOSE-UP: Dose Optimization for Smoking and E-Cigarette Use Pharmacotherapy
Conditions: Dual Use of Cigarettes and E-cigarettes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 321
Sponsor: Medical University of South Carolina
Location: Medical University of South Carolina Charleston South Carolina
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07754578). StuddyBuddy aggregates publicly available trial information.
