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Informing Oral Nicotine Pouch Regulations to Promote Public Health

StatusRecruiting
PhasePhase 2
Started2025-01-13
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
minor
Study Status v7
Re-verified, no change to tracked fields
2026-04-22
minor
Study Status, Oversight, Outcome Measures v6
Primary completion date2026-08-31→2028-01-31
Secondary endpoints+29 characters
ONP and Tobacco Purchase Task
2025-05-07
minor
Study Status, Contacts/Locations v5
Primary completion date2025-12-31→2026-08-31
Study sitescontacts updated at 1 of 1 site
2025-02-25
minor
Study Status v4
Completion date2027-12-31→2028-08-31
2025-02-11
minor
Study Status v3
Completion date2025-12-31→2027-12-31
Start dateestimated 2025-01-10→confirmed 2025-01-13
Show 2 earlier versions
2025-01-02
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2024-12-01→2025-01-10
Study sitesdetails revised at 1 of 1 site
2024-10-30
minor
Study Status, Oversight, Contacts/Locations v1
Start date2024-09-01→2024-12-01
Study sitescontacts updated at 1 of 1 site
2024-03-12
minor
Original filing
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.
Trial Details
NCT Number NCT06315881
Lead Sponsor Ohio State University Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Tobacco-Related Carcinoma
Enrollment 160 participants
Start Date 2025-01-13
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-17