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

ConditionDual Use of Cigarettes and E-cigarettes

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMedical University of South Carolina

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

321 Participants

are divided into 3 treatment groups

Group A: Behavioral SupportActive comparator 1 intervention

Group B: Standard dose NRTExperimental treatment 3 interventions

Group C: High dose NRTExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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