Skip to main content
OpenTrials
Completed

NCT Number: NCT05730439

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tobacco-Related Carcinoma

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

PRIMARY OBJECTIVES:

I. Assess appeal, perceived substitutability, and nicotine delivery of nicotine pouches (NPs) with high versus (vs.) low free-base nicotine (FBN) content among rural and Appalachian moist snuff users.

II. Evaluate whether smokeless tobacco (SLT) dependence modifies effects of NP FBN content on product appeal, perceived substitutability, and nicotine delivery.

OUTLINE: Participants are randomized to 1 of 6 arms.

ARM I: Participants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine pouch at study visit 2, and Rogue brand nicotine pouch at study visit 3. Participants also undergo intravenous (IV) line insertion and collection of blood on study.

ARM II: Participants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine pouch at study visit 2, and ZYN brand nicotine pouch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

ARM III: Participants receive ZYN brand nicotine pouch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and Rogue brand nicotine pouch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

ARM IV: Participants receive ZYN brand nicotine pouch at study visit 1, Rogue brand nicotine pouch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

ARM V: Participants receive Rogue brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

ARM VI: Participants receive Rogue brand nicotine pouch at study visit 1, ZYN brand nicotine pouch at study visit 2, and their usual brand of smokeless tobacco at study visit 3. Participants also undergo IV line insertion and collection of blood on study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Nicotine Oral Pouch

Drug

Receive ZYN brand NP

Other names: ZYN

Questionnaire Administration

Other

Ancillary studies

Smokeless Tobacco

Drug

Receive usual SLT

Other names: Smoking, Tobacco and Cancer - Smokeless Tobacco

Primary outcomes

  1. Plasma nicotine delivery (Aim 1)

    Time frame: From baseline to study completion, assessed up to 2 years

    Will use linear or logistic mixed effects regression models as appropriate (with a random subject effect) to assess the effects of product type on plasma nicotine delivery. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.

  2. Behavioral intentions (Aim 1)

    Time frame: From baseline to study completion, assessed up to 2 years

    Will use linear or logistic mixed effects regression models as appropriate (with a random subject effect) to assess behavioral intentions with regard to nicotine pouches (NPs). Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.

  3. Baseline characteristics (Aim 1)

    Time frame: From baseline to study completion, assessed up to 2 years

    Will use linear or logistic mixed effects regression models as appropriate (with a random subject effect) to control for baseline characteristics found to be associated with the outcome. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.

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

    Time frame: From baseline to study completion, assessed up to 2 years

    Will use linear or logistic mixed effects regression models as appropriate to assess the effects of product type on behavioral intentions. Statistical significance of the interaction terms will be determined using Wald tests. Models will additionally control for baseline characteristics found to be associated with the outcome. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.

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

    Time frame: From baseline to study completion, assessed up to 2 years

    Will use linear or logistic mixed effects regression models as appropriate to assess the effects of product type between the two-level indicator for SLT dependence (low/moderate vs. high). Statistical significance of the interaction terms will be determined using Wald tests. Models will additionally control for baseline characteristics found to be associated with the outcome. Model assumptions will be checked, and variables will be transformed as needed. Missing data will not be imputed as likelihood based linear mixed models will yield valid inference under missing at random assumptions. Calculated power to detect differences in maximum nicotine concentration using repeated measures ANOVA.

Secondary outcomes

  1. ONP and Smokeless Tobacco Purchase Task (Aims 1 and 2)

    Time frame: From baseline to study completion, assessed up to 2 years

    Data will be used to assess the prices participants would be willing to pay for each unit of product. Using demand curves generated from self-report data for each product, we will be able to determine how participants' usual brand of SLT compares to ONPs at different price points.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 15, 2023
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.