Cigarette SmokingPack2PouchNCT06678789
Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches
A study testing High Nicotine Dose and Low Nicotine Dose in people with Cigarette Smoking and Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Nicotine Dependence, Smoking Cessation
- What is being tested?
- High Nicotine Dose and Low Nicotine Dose
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to 28 May 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21+
- current cigarette smoking (25+ days per previous month, 5 or more cigarettes/day, for greater than 1yr, greater than 100 lifetime cigarettes)
- have not used TNFPs more than 5 times during their lifetime
- willing and able to attend 2 in-person visits in Charleston (to assess biomarkers)
- have internet access
Who cannot join
- Lack of proficiency in English.
- Use of other combustible tobacco products (i.e., cigars, cigarillos, hookahs) and/or other non-combusted nicotine/tobacco products (i.e., e-cigarettes, smokeless tobacco) in the past 30 days.
- Current use of smoking cessation medications (i.e., varenicline, bupropion, nicotine replacement therapy).
- Use of marijuana within the past month, and unwillingness to abstain from marijuana during course of study.
- Medical conditions contraindicated to NRT use (including pregnancy, breastfeeding, and nursing, past month myocardial infarction, current untreated cardiac arrhythmia, current severe angina, current uncontrolled severe vascular disease).
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, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches as a Harm Reducing Substitute for Combustible Cigarettes - (Pack2Pouch)
Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.
Read the detailed description
The proposed research project evaluates the potential for tobacco-free oral nicotine pouches (TFNPs) to serve as harm reduction tools at two nicotine concentrations, inclusive of behavioral and biomarker outcomes, using a clinical trial design. Specifically, in a randomized pilot study, participants who smoke will be recruited and sent TFNPs to sample for 4 weeks in either high (6 mg) or low (3 mg) nicotine content strengths. Participants will report tobacco use behaviors and submit biological samples throughout the study. This design allows for evaluation of the effect of nicotine content within alternative, harm-reducing tobacco products on key outcomes including: 1) complete switching from cigarette smoking to non-cigarette product use; 2) cigarette smoking reduction; 3) changes in biomarkers of harm (DNA damage, respiratory symptoms), 4) nicotine dependence, and 5) subjective effects of product use.
- Conditions
- Cigarette Smoking, Nicotine Dependence, Smoking Cessation
- Being tested
- High Nicotine Dose, Low Nicotine Dose
- Keywords
- Smoking
- Medical subject headings
- Cigarette Smoking, Tobacco Use Disorder, Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Nicotine DoseBehavioural
Will receive a 5-week supply of 6 mg Zyn pouches. Those who smoke 5-20 cigarettes per day will receive 1 tin per day = 35 tins, whereas those who smoke more will receive 2 tins/day [70 tins])
Low Nicotine DoseBehavioural
Will receive a 5-week supply of 3 mg Zyn pouches. Those who smoke 5-20 cigarettes per day will receive 1 tin per day = 35 tins, whereas those who smoke more will receive 2 tins/day [70 tins])
| Study group | Role | What they receive |
|---|---|---|
| High Nicotine | Experimental | High dosage nicotine pouches (6mg) Receives: Behavioral: High Nicotine Dose |
| Low Nicotine | Experimental | Low dosage nicotine pouches (3mg) Receives: Behavioral: Low Nicotine Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Switching
Switching will be defined at 7-day point-prevalence biochemically-confirmed abstinence from cigarettes alongside self-reported use of nicotine pouches. Non-responders and missing data will be coded as smoking.
Measured: Day 28 and Day 56
Smoking Reduction
Baseline and daily survey data will be used to calculate the change of smoking (average cigarettes per day) between groups from baseline to end of sampling.
Measured: Day 28 and Day 56
Secondary outcomes (1)
Tobacco-Free Oral Nicotine Pouches (TFNP) Use
Daily surveys will capture number of days of TFNP use, regardless of smoking.
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 posted7 Nov 2024
- Study start14 Feb 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion28 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- 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
- NCT06678789
- Sponsor's protocol ID
- Pro00139710
- Other IDs
- 5K12DA031794
- Acronym
- Pack2Pouch
- Status last verified
- Dec 2025
- First submitted
- 1 Nov 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified self-report data and outcomes from biosample analyses will be shared upon reasonable request. Biological samples will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches as a Harm Reducing Substitute for Combustible Cigarettes - (Pack2Pouch)
- ClinicalTrials.gov ID
- NCT06678789
- Acronym / sponsor ID
- Pack2Pouch / Pro00139710
- Conditions
- Cigarette Smoking, Nicotine Dependence, Smoking Cessation
- Keywords
- Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 28 May 2027 (estimated)
- First posted
- 7 Nov 2024 (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.
Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.
Detailed description
The proposed research project evaluates the potential for tobacco-free oral nicotine pouches (TFNPs) to serve as harm reduction tools at two nicotine concentrations, inclusive of behavioral and biomarker outcomes, using a clinical trial design. Specifically, in a randomized pilot study, participants who smoke will be recruited and sent TFNPs to sample for 4 weeks in either high (6 mg) or low (3 mg) nicotine content strengths. Participants will report tobacco use behaviors and submit biological samples throughout the study. This design allows for evaluation of the effect of nicotine content within alternative, harm-reducing tobacco products on key outcomes including: 1) complete switching from cigarette smoking to non-cigarette product use; 2) cigarette smoking reduction; 3) changes in biomarkers of harm (DNA damage, respiratory symptoms), 4) nicotine dependence, and 5) subjective effects of product use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Nicotine | Experimental | Behavioral: High Nicotine DoseHigh dosage nicotine pouches (6mg) |
| Low Nicotine | Experimental | Behavioral: Low Nicotine DoseLow dosage nicotine pouches (3mg) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21+
- current cigarette smoking (25+ days per previous month, 5 or more cigarettes/day, for greater than 1yr, greater than 100 lifetime cigarettes)
- have not used TNFPs more than 5 times during their lifetime
- willing and able to attend 2 in-person visits in Charleston (to assess biomarkers)
- have internet access
Key exclusion criteria (5 listed)
- Lack of proficiency in English.
- Use of other combustible tobacco products (i.e., cigars, cigarillos, hookahs) and/or other non-combusted nicotine/tobacco products (i.e., e-cigarettes, smokeless tobacco) in the past 30 days.
- Current use of smoking cessation medications (i.e., varenicline, bupropion, nicotine replacement therapy).
- Use of marijuana within the past month, and unwillingness to abstain from marijuana during course of study.
- Medical conditions contraindicated to NRT use (including pregnancy, breastfeeding, and nursing, past month myocardial infarction, current untreated cardiac arrhythmia, current severe angina, current uncontrolled severe vascular disease).
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 |
|---|---|---|
| High Nicotine DoseWill receive a 5-week supply of 6 mg Zyn pouches. Those who smoke 5-20 cigarettes per day will receive 1 tin per day = 35 tins, whereas those who smoke more will receive 2 tins/day [70 tins]) | Behavioural | High Nicotine |
| Low Nicotine DoseWill receive a 5-week supply of 3 mg Zyn pouches. Those who smoke 5-20 cigarettes per day will receive 1 tin per day = 35 tins, whereas those who smoke more will receive 2 tins/day [70 tins]) | Behavioural | Low Nicotine |
Primary outcome
Switching
Time frame: Day 28 and Day 56
Switching will be defined at 7-day point-prevalence biochemically-confirmed abstinence from cigarettes alongside self-reported use of nicotine pouches. Non-responders and missing data will be coded as smoking.
Smoking Reduction
Time frame: Day 28 and Day 56
Baseline and daily survey data will be used to calculate the change of smoking (average cigarettes per day) between groups from baseline to end of sampling.
1 secondary outcome
Tobacco-Free Oral Nicotine Pouches (TFNP) Use
Time frame: Day 28
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 20 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified self-report data and outcomes from biosample analyses will be shared upon reasonable request. Biological samples will not be shared.
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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 study testing High Nicotine Dose and Low Nicotine Dose in people with Cigarette Smoking and Nicotine Dependence, 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: looking for participants now, as of the sponsor's last update on 20 Aug 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.
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 Talia Ogretman (843-259-8111, ogretmet@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Switching (time frame: Day 28 and Day 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 20 Aug 2026.