Comparing e-cigarettes and nicotine pouches for reducing cigarette smoking
Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction
This study is testing whether e-cigarettes or nicotine pouches help adult smokers cut down on their cigarette use over four weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06077240 on ClinicalTrials.gov |
What this trial studies
This study aims to recruit 256 adult smokers who are willing to switch to alternative, non-combustible products. Participants will be randomly assigned to use either e-cigarettes or nicotine pouches over a 4-week period, with variations in flavor availability and nicotine concentration. They will attend bi-weekly visits to monitor their smoking behaviors and product usage, culminating in a follow-up at Week 6 to evaluate the effectiveness of the products in reducing cigarette consumption. The study is designed to identify which product characteristics are most effective in promoting smoking reduction.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older who currently smoke cigarettes and are not planning to use cessation therapies in the near future.
Not a fit: Patients who are currently using smoking cessation services or pharmacotherapies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective alternatives for smokers looking to reduce or quit cigarette use.
How similar studies have performed: Previous studies have shown promise in using alternative nicotine products for smoking reduction, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 21+ years old * English literate * Currently smoking cigarettes, biochemically confirmed Exclusion Criteria: * Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline) * Currently pregnant or breastfeeding * Significant current medical or psychiatric condition * Known hypersensitivity to propylene glycol
Where this trial is running
New Haven, Connecticut
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Fucito, PhD — Yale University
- Study coordinator: Lisa M. Fucito, PhD
- Email: lisa.fucito@yale.edu
- Phone: 203-200-1470
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.