CompletedEarly Phase 1

Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population

United States55 participantsStarted 2022-03-01

Plain-language summary

This clinical trial estimates the abuse liability of nicotine pouches with varying nicotine concentrations relative to cigarette smoking in Appalachian, Ohio and Ohio smokers. Nicotine pouches are a novel tobacco product with potential to reduce or increase the harm of tobacco use. Evaluating nicotine pouches abuse liability among smokers in Ohio including the unique demographic of Appalachia may clarify the public health effect of NPs in Appalachian Ohio and across Ohio. Results may inform public health efforts, policy, and clinical care aimed at reducing tobacco-related disparities.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Aim 1 Inclusion Criteria: * Age 21 years or older. * Reside in an Ohio Appalachian county. * Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits. * Ability to read and speak English. * Smoke at least 5 cigarettes per day for the past 30 days. Exclusion Criteria: * Use tobacco products other than cigarettes \>10 days per month. * Use NP in the past 3 months. * Unstable or significant psychiatric conditions (past and stable conditions will be allowed). * Pregnant, planning to become pregnant, or breastfeeding. * History of cardiac event or distress within the past 3 months. * Currently attempting to quit all tobacco use. * Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease. Aim 2 Inclusion Criteria: * Age 21 years or older. * Reside in a Ohio. * Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits. * Ability to read and speak English. * Smoke at least 5 cigarettes per day for the past 30 days. Exclusion Criteria: * Use tobacco products other than cigarettes \>10 days per month. * Use NP in the past 3 months. * Unstable or significant psychiatric conditions (past and stable conditions will be allowed). * Pregnant, planning to become pregnant, or breastfeeding. * History of cardiac event or distress within the…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested nicotine pouches against cigarettes in people from Ohio Appalachia — since it focused on measuring nicotine levels in the blood at 30 minutes after use, what did the results actually show about how differently these products deliver nicotine to the body?
2Since this was an early Phase 1 study that has now completed, has enough safety and outcome data been published for you to tell me whether nicotine pouches are considered a safer or medically accepted alternative to cigarettes for someone at risk of smoking-related cancer?
3The trial specifically studied an Appalachian population — does that community context or the nicotine pouch findings change how you'd counsel me about switching away from cigarettes, or is this still too early-stage to guide that decision?
4Given that this study only measured nicotine concentration at one point in time (30 minutes), does that limited snapshot tell us anything useful about long-term addiction risk or cancer risk from nicotine pouches compared to cigarettes?
5Are there now any follow-up studies or standard clinical guidelines based on this research that we should consider when thinking about tobacco harm reduction options for my situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate plasma nicotine concentration at t=30 minutes for each product.

Timeframe: Up to 6 months

Trial details

NCT IDNCT05236894

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-18

View on ClinicalTrials.gov More Cigarette Smoking-Related Carcinoma trials