Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for early_phase_1

Timeline

Completed

Started May 2023

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

February 6, 2023

Completed

9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed

3 months until next milestone

Study Start

First participant enrolled

May 19, 2023

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2024

Completed

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

February 6, 2023

Last Update Submit

April 22, 2026

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (5)

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.
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.
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.
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.
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.
From baseline to study completion, assessed up to 2 years

Secondary Outcomes (1)

ONP and Smokeless Tobacco Purchase Task (Aims 1 and 2)
From baseline to study completion, assessed up to 2 years

Study Arms (6)

Arm I (usual SLT, ZYN NP, Rogue NP)

EXPERIMENTAL

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.