Informing Oral Nicotine Pouch Regulations to Promote Public Health

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.

Conditions

• Tobacco-Related Carcinoma

Interventions

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Brittney L Keller-Hamilton, PhD, MPH · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-13

Primary Completion

2028-01-31

Completion

2028-08-31

FDA Drug

Yes

Countries

• United States

Study Locations