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

Tobacco-Related Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730439
• Other study ID #: OSU-22197
• Secondary ID: NCI-2023-00134
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 12, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco-Related Carcinoma

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood

Drug:
• Nicotine Oral Pouch
Receive ZYN brand NP
• Nicotine Oral Pouch
Receive Rogue brand NP

Other:
• Questionnaire Administration
Ancillary studies

Drug:
• Smokeless Tobacco
Receive usual SLT

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

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