RecruitingPhase 2NCT06315881

Informing Oral Nicotine Pouch Regulations to Promote Public Health


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

160 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a drug called Cigarette, and others for people with tobacco-related carcinoma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample and oral mucosa sample collection

DRUGCigarette

Smoke usual brand cigarette

DRUGNicotine Oral Pouch

Insert low FBN R/S ONP

DRUGNicotine Oral Pouch

Insert low FBN \> 99% S ONP

DRUGNicotine Oral Pouch

Insert high R/S ONP

DRUGNicotine Oral Pouch

Insert high FBN \> 99% ONP

DRUGSmokeless Tobacco

Insert ST

OTHERSurvey Administration

Ancillary studies

OTHERText Message-Based Navigation Intervention

Receive text with a link to daily diary surveys


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT06315881


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