Smoking ( Cigarette)Phase 4Pack2Pouch+NCT07625956
Piloting Novel Interventional Strategies to Improve Nicotine Pouches as a Substitute for Smoking
A Phase 4 study testing Nicotine replacement therapy patches and Oral nicotine pouches in people with Smoking ( Cigarette), run by Medical University of South Carolina at 1 site in United States.
Trial summary
Some people who smoke cigarettes try to switch to oral nicotine pouches but are not able to fully stop smoking. This study tests two new strategies for people who previously tried to switch using nicotine pouches. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Smoking ( Cigarette)
- What is being tested?
- Nicotine replacement therapy patches and Oral nicotine pouches
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2026to Oct 2026
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years or older
- Currently enrolled in and completed the Pack2Pouch parent study
- Current combustible tobacco smoking at extension study enrollment
- Able to attend in-person visits in the Charleston, SC area
- Access to internet and mobile communication
Who cannot join
- Pregnancy, breastfeeding, or nursing
- Medical contraindications to nicotine replacement therapy
- Current use of smoking cessation medications
- Non-English proficiency
- Use of other combustible tobacco or frequent non-combustible nicotine products outside study protocol
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 Universtiy of South Carolina
Charleston, South Carolina, 29425
About this study
Some people who smoke cigarettes try to switch to oral nicotine pouches but are not able to fully stop smoking. This study tests two new strategies for people who previously tried to switch using nicotine pouches. Participants who were unable to fully switch will either be asked to increase the nicotine strength of their pouches or to use a nicotine patch along with pouches. The goal of the study is to see whether these strategies are feasible, acceptable, and helpful, and to inform the design of larger future studies.
- Conditions
- Smoking ( Cigarette)
- Being tested
- Nicotine replacement therapy patches, Oral nicotine pouches
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine replacement therapy patchesDrug
Nicotine replacement therapy patches will be dosed based on current cigarette smoking at the end of the parent trial.
Oral nicotine pouchesDrug
Zyn oral nicotine pouches will be provided in the flavor preference of the participant and dosed based on their randomization in the parent trial and randomization in the extension study.
| Study group | Role | What they receive |
|---|---|---|
| Increase | Active comparator | Increase nicotine content of pouches Receives: Drug: Oral nicotine pouches |
| Augment | Active comparator | Add nicotine replacement therapy Receives: Drug: Nicotine replacement therapy patches |
| Continue | No intervention | Participants will continue with their treatment from the parent trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility endpoints include 1) the proportion of eligible subjects who subsequently enroll; 2) the proportion of enrolled subjects who complete the Day 28 and Day 56 assessments; and 3) the proportion of enrolled subjects who complete ≥80% of their daily surveys during the switching period.
Measured: Days 1-56
Acceptability
Acceptability endpoints will be measured by the Acceptability of Intervention Measure (AIM). This measure includes 4 items rated on scale of 1 to 5. Scores are created by averaging responses, with values ranging from 1 to 5. Higher values indicate higher acceptability.
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 posted4 Jun 2026
- Study start26 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking ( Cigarette)Studies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Palmer, Medical University of South Carolina
- Investigators
- Amanda Palmer, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625956
- Sponsor's protocol ID
- Pro00150364
- Acronym
- Pack2Pouch+
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study may be shared, by reasonable request, with other investigators not affiliated with the tobacco industry.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Novel Interventional Strategies to Improve Nicotine Pouches as a Substitute for Smoking
- ClinicalTrials.gov ID
- NCT07625956
- Acronym / sponsor ID
- Pack2Pouch+ / Pro00150364
- Conditions
- Smoking ( Cigarette)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 4 Jun 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.
Some people who smoke cigarettes try to switch to oral nicotine pouches but are not able to fully stop smoking. This study tests two new strategies for people who previously tried to switch using nicotine pouches. Participants who were unable to fully switch will either be asked to increase the nicotine strength of their pouches or to use a nicotine patch along with pouches. The goal of the study is to see whether these strategies are feasible, acceptable, and helpful, and to inform the design of larger future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Increase | Active comparator | Drug: Oral nicotine pouchesIncrease nicotine content of pouches |
| Augment | Active comparator | Drug: Nicotine replacement therapy patchesAdd nicotine replacement therapy |
| Continue | No intervention | –Participants will continue with their treatment from the parent trial. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21 years or older
- Currently enrolled in and completed the Pack2Pouch parent study
- Current combustible tobacco smoking at extension study enrollment
- Able to attend in-person visits in the Charleston, SC area
- Access to internet and mobile communication
Key exclusion criteria (5 listed)
- Pregnancy, breastfeeding, or nursing
- Medical contraindications to nicotine replacement therapy
- Current use of smoking cessation medications
- Non-English proficiency
- Use of other combustible tobacco or frequent non-combustible nicotine products outside study protocol
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 |
|---|---|---|
| Nicotine replacement therapy patchesNicotine replacement therapy patches will be dosed based on current cigarette smoking at the end of the parent trial. | Drug | Augment |
| Oral nicotine pouchesZyn oral nicotine pouches will be provided in the flavor preference of the participant and dosed based on their randomization in the parent trial and randomization in the extension study. | Drug | Increase |
Primary outcome
Feasibility
Time frame: Days 1-56
Feasibility endpoints include 1) the proportion of eligible subjects who subsequently enroll; 2) the proportion of enrolled subjects who complete the Day 28 and Day 56 assessments; and 3) the proportion of enrolled subjects who complete ≥80% of their daily surveys during the switching period.
Acceptability
Time frame: Day 28
Acceptability endpoints will be measured by the Acceptability of Intervention Measure (AIM). This measure includes 4 items rated on scale of 1 to 5. Scores are created by averaging responses, with values ranging from 1 to 5. Higher values indicate higher acceptability.
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 6 Jul 2026.
- Individual participant dataSharing planned: Yes. Data from this study may be shared, by reasonable request, with other investigators not affiliated with the tobacco industry.
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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.
Amanda Palmer, PhD 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 4 study testing Nicotine replacement therapy patches and Oral nicotine pouches in people with Smoking ( Cigarette), 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 5 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 6 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Feasibility (time frame: Days 1-56). 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 6 Jul 2026.