Smoking CessationPhase 2CAN-DOSENCT06087328
CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes
A Phase 2 study testing Regular Nicotine patch and lozenge dose and Augmented Nicotine patch and lozenge dose in people with Smoking Cessation and Electronic Cigarette Use, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Electronic Cigarette Use, Cigarette Smoking
- What is being tested?
- Regular Nicotine patch and lozenge dose and Augmented Nicotine patch and lozenge dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 5 Nov 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18yrs +
- Daily nicotine-containing e-cigarette user (25+ days per previous month)
- E-cigarette use 5+ times/day
- E-cigarette use > 1year
- Smoking >1 cigarette on 5-7 days per week
- Interest in quitting smoking and e-cigarette within the next month (>7 on 10-point scale)
Show all 9Show fewer
- Willingness to use NRT
- Able to receive text messages/email
- Mailing address in South Carolina.
Who cannot join
- Medical conditions contraindicated to NRT use (including pregnancy, past month myocardial infarction, current cardiac arrhythmia, current angina, uncontrolled vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated)
- Individuals reporting current use of other nicotine-containing products and/or smoking cessation medications
- Those who vape non-nicotine substances
- Individuals unable to consent (e.g. significant cognitive deficit, non-English speaking).
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina - Charleston
Charleston, South Carolina, 29403
About this study
Official title: Comparing the Effects of Augmented Doses of Nicotine Replacement Therapy on Quitting Cigarettes and E-cigarettes
Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.
Read the detailed description
Tobacco use is a leading cause of cancer death and disability in the US, thus tobacco control remains an important public health priority. Alternative tobacco products have grown popular in the past decade, including electronic cigarettes (e-cigarettes; vaping). E-cigarettes were initially marketed as an alternative to or means for smoking cessation and became popular amongst those currently smoking. Recent estimates suggest that 54% of those who vape are currently smoking (i.e., dual use). Despite this, there is a lack of empirically tested interventions for dual use cessation among the general adult population. In a prior pilot study, investigators found preliminary evidence that a standard dose of nicotine replacement therapy (NRT; 21mg patch+4mg lozenge) was sufficient at helping exclusive e-cigarette users quit vaping. However, dual users (individuals who smoke cigarettes and use e-cigarettes) did not respond similarly. The proposed project aims to compare three doses of NRT (21mg patch+4mg lozenge; 21+14mg patch + 4mg lozenges; 21+21mg patch + 4mg lozenges) with a sample of dual users who wish to quit smoking and vaping use in order to understand more about how NRT can help dual users quit tobacco.
- Being tested
- Regular Nicotine patch and lozenge dose, Augmented Nicotine patch and lozenge dose
- Medical subject headings
- Smoking Cessation, Vaping, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Nicotine patch and lozenge doseDrug
1mg patch, qd + 4mg lozenge prn [minimum of 5 \& up to 20 per day]
Augmented Nicotine patch and lozenge doseDrug
21mg patch + 14mg patch qd + 4mg lozenge prn [minimum of 5 \& up to 30 per day] OR 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 \& up to 40 per day]
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | 21mg patch, qd + 4mg lozenge prn [minimum of 5 \& up to 20 per day] Receives: Drug: Regular Nicotine patch and lozenge dose |
| Arm B | Active comparator | 21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& [up to 30 per day] Receives: Drug: Augmented Nicotine patch and lozenge dose |
| Arm C | Active comparator | 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 \& up to 40 per day] Receives: Drug: Augmented Nicotine patch and lozenge dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Dual Use Abstinence
Number of days participants self-report abstinence from both e-cigarettes and smoking.
Measured: Day 28, Day 56
Secondary outcomes (3)
Reduction
Calculate the reduction of e-cigarette use and smoking between groups from baseline to end of treatment.
Measured: Day 28, Day 56
Safety (Adverse Events)
Adverse events and outcomes between groups will be evaluated.
Measured: Day 28
Feasibility/Acceptability
Feasibility and acceptability were assessed by the proportion of eligible participants who enrolled, and among enrolled participants, the proportion who completed the Day 28 survey and the proportion who completed ≥80% of daily surveys during treatment.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start5 Dec 2023
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Amanda Palmer, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087328
- Sponsor's protocol ID
- Pro00130184
- Other IDs
- IRG-19-137-20
- Acronym
- CAN-DOSE
- Status last verified
- Nov 2025
- First submitted
- 12 Oct 2023
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Palmer AM, DeMass R, Rojewski AM, Bagley EM, Carpenter MJ, Smith TT, Toll BA. Augmented Doses of Nicotine Replacement Therapy: Feasibility for Dual Cigarette and E-Cigarette Cessation. Am J Prev Med. 2025 Aug;69(2):107664. doi: 10.1016/j.amepre.2025.107664. Epub 2025 May 21.
PubMed 40409566
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Augmented Doses of Nicotine Replacement Therapy on Quitting Cigarettes and E-cigarettes
- ClinicalTrials.gov ID
- NCT06087328
- Acronym / sponsor ID
- CAN-DOSE / Pro00130184
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Posted 26 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.
Detailed description
Tobacco use is a leading cause of cancer death and disability in the US, thus tobacco control remains an important public health priority. Alternative tobacco products have grown popular in the past decade, including electronic cigarettes (e-cigarettes; vaping). E-cigarettes were initially marketed as an alternative to or means for smoking cessation and became popular amongst those currently smoking. Recent estimates suggest that 54% of those who vape are currently smoking (i.e., dual use). Despite this, there is a lack of empirically tested interventions for dual use cessation among the general adult population. In a prior pilot study, investigators found preliminary evidence that a standard dose of nicotine replacement therapy (NRT; 21mg patch+4mg lozenge) was sufficient at helping exclusive e-cigarette users quit vaping. However, dual users (individuals who smoke cigarettes and use e-cigarettes) did not respond similarly. The proposed project aims to compare three doses of NRT (21mg patch+4mg lozenge; 21+14mg patch + 4mg lozenges; 21+21mg patch + 4mg lozenges) with a sample of dual users who wish to quit smoking and vaping use in order to understand more about how NRT can help dual users quit tobacco.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Regular Nicotine patch and lozenge dose21mg patch, qd + 4mg lozenge prn [minimum of 5 \& up to 20 per day] |
| Arm B | Active comparator | Drug: Augmented Nicotine patch and lozenge dose21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& [up to 30 per day] |
| Arm C | Active comparator | Drug: Augmented Nicotine patch and lozenge dose2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 \& up to 40 per day] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18yrs +
- Daily nicotine-containing e-cigarette user (25+ days per previous month)
- E-cigarette use 5+ times/day
- E-cigarette use > 1year
- Smoking >1 cigarette on 5-7 days per week
Key exclusion criteria (4 listed)
- Medical conditions contraindicated to NRT use (including pregnancy, past month myocardial infarction, current cardiac arrhythmia, current angina, uncontrolled vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated)
- Individuals reporting current use of other nicotine-containing products and/or smoking cessation medications
- Those who vape non-nicotine substances
- Individuals unable to consent (e.g. significant 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 |
|---|---|---|
| Regular Nicotine patch and lozenge dose1mg patch, qd + 4mg lozenge prn [minimum of 5 \& up to 20 per day] | Drug | Arm A |
| Augmented Nicotine patch and lozenge dose21mg patch + 14mg patch qd + 4mg lozenge prn [minimum of 5 \& up to 30 per day] OR 2 x 21mg patches qd + 4mg lozenges prn [minimum of 5 \& up to 40 per day] | Drug | Arm B, Arm C |
Primary outcome
Days of Dual Use Abstinence
Time frame: Day 28, Day 56
Number of days participants self-report abstinence from both e-cigarettes and smoking.
3 secondary outcomes
Reduction
Time frame: Day 28, Day 56
Safety (Adverse Events)
Time frame: Day 28
Feasibility/Acceptability
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40409566Palmer AM, DeMass R, Rojewski AM, Bagley EM, Carpenter MJ, Smith TT, Toll BA. Augmented Doses of Nicotine Replacement Therapy: Feasibility for Dual Cigarette and E-Cigarette Cessation. Am J Prev Med. 2025 Aug;69(2):107664. doi: 10.1016/j.amepre.2025.107664. Epub 2025 May 21.
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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. This study is not recruiting at the moment.
Amanda Palmer principal investigator
Medical University of South Carolina
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 Regular Nicotine patch and lozenge dose and Augmented Nicotine patch and lozenge dose in people with Smoking Cessation and Electronic Cigarette Use, 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 26 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of Dual Use Abstinence (time frame: Day 28, Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087328, which also lists 1 linked publication.
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 26 Nov 2025.