Dual Use of Cigarettes and E-cigarettesPhase 2NCT07754578
DOSE-UP: Dose Optimization for Smoking and E-Cigarette Use Pharmacotherapy
A Phase 2 study testing Text- and web-based support, Nicotine Replacement Therapy (NRT, nicotine patch) and Nicotine replacement therapy lozenge in people with Dual Use of Cigarettes and E-cigarettes, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dual Use of Cigarettes and E-cigarettes
- What is being tested?
- Text- and web-based support, Nicotine Replacement Therapy (NRT, nicotine patch) and Nicotine replacement therapy lozenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 10 Jul 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
- Conditions
- Dual Use of Cigarettes and E-cigarettes
- Being tested
- Text- and web-based support, Nicotine Replacement Therapy (NRT, nicotine patch), Nicotine replacement therapy lozenge
- Keywords
- tobacco, smoking, cigarette, e-cigarette, dual use
- Medical subject headings
- Vaping, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text- and web-based supportBehavioural
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 lozengeDrug
4mg; 5-20/day
Nicotine replacement therapy lozengeDrug
4mg; 5-30/day
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Support | Active comparator | Participants will receive behavioral support only. Receives: Behavioral: Text- and web-based support |
| Standard dose NRT | Experimental | Participants will receive a standard dose of nicotine replacement therapy (NRT). Receives: Behavioral: Text- and web-based support; Drug: Nicotine Replacement Therapy (NRT, nicotine patch); Drug: Nicotine replacement therapy lozenge |
| High dose NRT | Experimental | Participants will receive a higher dose of NRT than what is typically used. Receives: Behavioral: Text- and web-based support; Drug: Nicotine Replacement Therapy (NRT, nicotine patch); Drug: Nicotine replacement therapy lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Weeks 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion10 Apr 2030 (estimated)
- Study completion10 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual Use of Cigarettes and E-cigarettesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Amanda Palmer, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754578
- Sponsor's protocol ID
- Pro00150067
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Nicotine Replacement Therapy for Quitting Cigarettes and E-cigarettes
- ClinicalTrials.gov ID
- NCT07754578
- Acronym / sponsor ID
- Pro00150067
- Conditions
- Dual Use of Cigarettes and E-cigarettes
- Keywords
- tobacco, smoking, cigarette, e-cigarette, dual use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 10 Apr 2030 (estimated)
- Study completion
- 10 Jul 2031 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral Support | Active comparator | Behavioral: Text- and web-based supportParticipants will receive behavioral support only. |
| Standard dose NRT | Experimental | Behavioral: Text- and web-based support, Drug: Nicotine Replacement Therapy (NRT, nicotine patch), Drug: Nicotine replacement therapy lozengeParticipants will receive a standard dose of nicotine replacement therapy (NRT). |
| High dose NRT | Experimental | Behavioral: Text- and web-based support, Drug: Nicotine Replacement Therapy (NRT, nicotine patch), Drug: Nicotine replacement therapy lozengeParticipants will receive a higher dose of NRT than what is typically used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text- and web-based supportParticipants will enroll in the Ex Program for support in quitting smoking and vaping. | Behavioural | Behavioral Support, High dose NRT, Standard dose NRT |
| Nicotine Replacement Therapy (NRT, nicotine patch)21mg patch | Drug | Standard dose NRT |
| Nicotine Replacement Therapy (NRT, nicotine patch)21mg + 14mg patch | Drug | High dose NRT |
| Nicotine replacement therapy lozenge4mg; 5-20/day | Drug | Standard dose NRT |
| Nicotine replacement therapy lozenge4mg; 5-30/day | Drug | High dose NRT |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Text- and web-based support, Nicotine Replacement Therapy (NRT, nicotine patch) and Nicotine replacement therapy lozenge in people with Dual Use of Cigarettes and E-cigarettes, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Program Coordinator ((843)737-1516, chrisrac@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual use abstinence (time frame: Week 12, Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.