Evaluating nicotine pouches for quitting smoking
Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches as a Harm Reducing Substitute for Combustible Cigarettes - (Pack2Pouch)
This study is testing if tobacco-free nicotine pouches can help smokers switch from cigarettes by trying out different nicotine levels over 28 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06678789 on ClinicalTrials.gov |
What this trial studies
This study assesses the effectiveness of tobacco-free oral nicotine pouches at different nicotine levels in helping smokers switch from cigarettes. Participants will be recruited to use either high (6 mg) or low (3 mg) nicotine pouches over a 28-day period, during which they will provide feedback on their tobacco use and submit biological samples. The study aims to measure outcomes such as complete switching from cigarettes, reduction in smoking, changes in biomarkers of harm, and levels of nicotine dependence. Participants will attend two in-person visits at the Medical University of South Carolina for assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who are current cigarette smokers with a significant smoking history.
Not a fit: Patients who use other tobacco products or smoking cessation medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer alternative for smokers looking to quit by using nicotine pouches.
How similar studies have performed: Previous studies have shown promise in using nicotine pouches as harm reduction tools, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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).
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Amanda Palmer, PhD. — Medical University of South Carolina
- Study coordinator: Talia Ogretman
- Email: ogretmet@musc.edu
- Phone: 843-259-8111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.