Informing Oral Nicotine Pouch Regulations to Promote Public Health

PHASE2RecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

January 13, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2028

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

Trial Locations (1)

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Ohio State University Comprehensive Cancer Center

OTHER