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

August 7, 2026 updated by: Amanda Palmer, Medical University of South Carolina

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

321

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rachel Program Coordinator
  • Phone Number: (843)737-1516
  • Email: chrisrac@musc.edu

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Behavioral Support
Participants will receive behavioral support only.
Behavioral: Text- and web-based support
Participants will enroll in the Ex Program for support in quitting smoking and vaping.
Experimental: Standard dose NRT
Participants will receive a standard dose of nicotine replacement therapy (NRT).
Behavioral: Text- and web-based support
Participants will enroll in the Ex Program for support in quitting smoking and vaping.
Drug: Nicotine Replacement Therapy (NRT, nicotine patch)
21mg patch
Drug: Nicotine Replacement Therapy (NRT, nicotine patch)
21mg + 14mg patch
Drug: Nicotine replacement therapy lozenge
4mg; 5-20/day
Drug: Nicotine replacement therapy lozenge
4mg; 5-30/day
Experimental: High dose NRT
Participants will receive a higher dose of NRT than what is typically used.
Behavioral: Text- and web-based support
Participants will enroll in the Ex Program for support in quitting smoking and vaping.
Drug: Nicotine Replacement Therapy (NRT, nicotine patch)
21mg patch
Drug: Nicotine Replacement Therapy (NRT, nicotine patch)
21mg + 14mg patch
Drug: Nicotine replacement therapy lozenge
4mg; 5-20/day
Drug: Nicotine replacement therapy lozenge
4mg; 5-30/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12, Week 24
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.
Weeks 12, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 10, 2026

Primary Completion (Estimated)

April 10, 2030

Study Completion (Estimated)

July 10, 2031

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 4, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00150067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be uploaded to the National Institute of Mental Health (NIMH) Data Archive (NDA). All participant data uploaded to the repository will be de-identified. Shared data will include participants' self-reported survey responses, assessment scores, and results of biospecimen assays.

IPD Sharing Access Criteria

The NDA controls data access. Researchers need to request access, which is then decided upon by the NDA Data Access Committee. Standard NDA data access permits one-year access that is renewable.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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