An Early Phase 1 interventional study of Biospecimen Collection and Nicotine Oral Pouch in Tobacco-Related Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Ohio State University Comprehensive Cancer Center · Early Phase 1, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
Participants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine patch at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
Procedure: Biospecimen Collection · Drug: Nicotine Oral Pouch · Other: Questionnaire Administration · Drug: Smokeless Tobacco
Participants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine patch 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.
Procedure: Biospecimen Collection · Drug: Nicotine Oral Pouch · Other: Questionnaire Administration · Drug: Smokeless Tobacco
Participants receive ZYN brand nicotine patch at study visit 1, their usual brand of smokeless tobacco at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
Procedure: Biospecimen Collection · Drug: Nicotine Oral Pouch · Other: Questionnaire Administration · Drug: Smokeless Tobacco
Participants receive ZYN brand nicotine patch at study visit 1, Rogue brand nicotine patch 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.
Procedure: Biospecimen Collection · Drug: Nicotine Oral Pouch · Other: Questionnaire Administration · Drug: Smokeless Tobacco
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.
Procedure: Biospecimen Collection · Drug: Nicotine Oral Pouch · Other: Questionnaire Administration · Drug: Smokeless Tobacco
Participants receive Rogue brand nicotine patch at study visit 1, ZYN brand nicotine patch 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
Procedure: Biospecimen Collection · Drug: Nicotine Oral Pouch · Other: Questionnaire Administration · Drug: Smokeless Tobacco
Undergo collection of blood
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Receive ZYN brand NP
Also known as: ZYN
Receive Rogue brand NP
Also known as: Rogue
Ancillary studies
Receive usual SLT
Also known as: Smoking, Tobacco and Cancer - Smokeless Tobacco
Plasma nicotine delivery (Aim 1)
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.
Time frame: From baseline to study completion, assessed up to 2 years
Behavioral intentions (Aim 1)
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.
Time frame: From baseline to study completion, assessed up to 2 years
Baseline characteristics (Aim 1)
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.
Time frame: From baseline to study completion, assessed up to 2 years
Smokeless tobacco (SLT) type and behavioral intentions (Aim 2)
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.
Time frame: 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)
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.
Time frame: From baseline to study completion, assessed up to 2 years
ONP and Smokeless Tobacco Purchase Task (Aims 1 and 2)
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.
Time frame: From baseline to study completion, assessed up to 2 years
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center