Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07754578

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Dual Use of Cigarettes and E-cigarettes Behavior Smoking Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 lozenge

Drug

4mg; 5-20/day

Primary outcomes

  1. Dual use abstinence

    Time frame: Week 12, Week 24

    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.

  2. Cigarette abstinence

    Time frame: Weeks 12, Week 24

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Program Coordinator

CONTACT

[email protected]

(843)737-1516

Talia Program Assistant

CONTACT

[email protected]

843-259-8111

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

High-Dose Nicotine Replacement Therapy for Quitting Cigarettes and E-cigarettes

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Aug 10, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.