NCT05730439

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tobacco-Related Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood
DRUG	Nicotine Oral Pouch	Receive ZYN brand NP
DRUG	Nicotine Oral Pouch	Receive Rogue brand NP
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Smokeless Tobacco	Receive usual SLT

Timeline

• Start date: 2023-05-19
• Primary completion: 2024-01-30
• Completion: 2024-08-05
• First posted: 2023-02-15
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study