NCT06315881

Informing Oral Nicotine Pouch Regulations to Promote Public Health

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs.

Detailed description

PRIMARY OBJECTIVES: I. Assess the effects of nicotine concentration, form, and isomer on the satisfaction and appeal of ONPs relative to cigarettes and ST. II. Evaluate the effects of nicotine concentration, form, and isomer on switching from cigarettes or ST to ONPs. EXPLORATORY OBJECTIVE: I. Examine changes in oral microbiome-host interactions associated with degree of switching from cigarettes/ST to ONPs. OUTLINE: PHASE I: Participants are randomized to use one of the 4 study ONP products or their usual product brand of ST or cigarette in either the low or high nicotine concentration arm. ARM I: Participants insert low free-base nicotine (FBN) R/S ONP product over 30 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes. ARM II: Participants insert low FBN \> 99% S ONP product over 30 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes. ARM III: Participants insert high R/S ONP product over 30 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes. ARM IV: Participants insert high FBN \> 99% S ONP product over 30 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes. ARM V: Participants insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes. PHASE II: WASHOUT PERIOD: Participants use usual brand of ST or cigarettes for 1 week. CONTROL WEEK: Participants continue regular use of ST or cigarettes for 1 week and receive a text with a link to daily diary surveys to record tobacco use. PHASE II SWITCH: Participants are randomized to switch to 1 of 4 study ONP. ARM I: Participants insert low FBN R/S ONP for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection. ARM II: Participants insert to low FBN \> 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection. ARM III: Participants insert to high R/S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection. ARM IV: Participants insert high FBN \> 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.

Conditions

• Tobacco-Related Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample and oral mucosa sample collection
DRUG	Cigarette	Smoke usual brand cigarette
DRUG	Nicotine Oral Pouch	Insert low FBN R/S ONP
DRUG	Nicotine Oral Pouch	Insert low FBN \> 99% S ONP
DRUG	Nicotine Oral Pouch	Insert high R/S ONP
DRUG	Nicotine Oral Pouch	Insert high FBN \> 99% ONP
DRUG	Smokeless Tobacco	Insert ST
OTHER	Survey Administration	Ancillary studies
OTHER	Text Message-Based Navigation Intervention	Receive text with a link to daily diary surveys

Timeline

• Start date: 2025-01-13
• Primary completion: 2026-08-31
• Completion: 2028-08-31
• First posted: 2024-03-18
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study