CompletedEarly Phase 1

Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia

United States71 participantsStarted 2023-05-19

Plain-language summary

This clinical trial examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents. Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity. There is little research on how nicotine pouches will be adopted by residents of Ohio Appalachia and rural Ohio. This study may help researchers better understand the appeal and potential impact of nicotine pouches on public health.

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.

Inclusion Criteria: * Age 21 years or older * Reside in an Ohio Appalachian county or surrounding rural area * 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 * Daily use of smokeless tobacco for the past 3 months Exclusion Criteria: * Use tobacco products other than smokeless tobacco \> 10 days per month * Unstable or significant psychiatric conditions for \> 1 year (past and stable conditions will be allowed) * Pregnant, planning to become pregnant, or breastfeeding * History of cardiac event or distress, including but not limited to uncontrolled high blood pressure, chest pain, significant oral lesions, throat, mouth, or other oral cancer, and shortness of breath within the past 1 year * Working with a cessation counselor, using cessation devices such as Chantix or Wellbutrin, or planning to quit within the next 3 months * Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, throat, tongue, or other oral cancer, lung cancer, or chronic obstructive pulmonary disease

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 is listed as completed and was an early Phase 1 study focused mainly on measuring nicotine delivery and behavioral intentions rather than treating cancer — so what actual treatment benefit, if any, could someone with a tobacco-related carcinoma expect from research like this, versus pursuing an established treatment plan?
2Since this study looked at nicotine pouches and smokeless tobacco use in rural Ohio and Appalachian communities, does my own history with smokeless tobacco or nicotine products make this kind of research relevant to understanding my cancer risk or diagnosis?
3Because this was an early Phase 1 observational study measuring things like plasma nicotine levels and product appeal rather than testing a therapy, does my doctor think the findings from this trial should influence any part of my current care or tobacco cessation support?
4Given that this trial studied nicotine pouch use and dependence, should I be talking with my care team about a formal nicotine dependence assessment, especially if I currently use or have used smokeless tobacco products?
5Are there other studies or treatment trials that built on this kind of early research that my doctor thinks might be more directly relevant to my situation right now?

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

Plasma nicotine delivery (Aim 1)

Timeframe: From baseline to study completion, assessed up to 2 years

Behavioral intentions (Aim 1)

Timeframe: From baseline to study completion, assessed up to 2 years

Baseline characteristics (Aim 1)

Timeframe: From baseline to study completion, assessed up to 2 years

Smokeless tobacco (SLT) type and behavioral intentions (Aim 2)

Timeframe: From baseline to study completion, assessed up to 2 years

Smokeless tobacco (SLT) dependence effects on NP free-base nicotine (FBN) content on product appeal (Aim 2)

Timeframe: From baseline to study completion, assessed up to 2 years

Trial details

NCT IDNCT05730439

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-30

View on ClinicalTrials.gov More Tobacco-Related Carcinoma trials

Plain-language summary

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.

What they're measuring

Plasma nicotine delivery (Aim 1)

Timeframe: From baseline to study completion, assessed up to 2 years

Behavioral intentions (Aim 1)

Timeframe: From baseline to study completion, assessed up to 2 years

Baseline characteristics (Aim 1)

Timeframe: From baseline to study completion, assessed up to 2 years

Smokeless tobacco (SLT) type and behavioral intentions (Aim 2)

Timeframe: From baseline to study completion, assessed up to 2 years

Smokeless tobacco (SLT) dependence effects on NP free-base nicotine (FBN) content on product appeal (Aim 2)

Timeframe: From baseline to study completion, assessed up to 2 years