Recruiting
Phase 2

Observational Study

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06315881

Conditions

Tobacco-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Cigarette

Nicotine Oral Pouch

Nicotine Oral Pouch

Nicotine Oral Pouch

Study Details

Brief 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

Study ID

NCT06315881

Start date

Jan 13, 2025

Status verified date

Aug, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Read and speak English
  • At least 21 years old
  • Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to Phase 1 study visits
  • Willing to attend all study visits and use study ONPs
  • Owns a smartphone and able to receive short messaging service (SMS) text messages with embedded survey link (for daily diary reports of ONP and other tobacco use)
  • Negative pregnancy test produced during Phase 1 visits 1-5 and Phase 2 visit 1 if capable of becoming pregnant
  • Exhaled carbon monoxide (CO) reading < 10 (Phase 1)
  • CIGARETTE SMOKERS ONLY: Established cigarette smoker (has smoked at least 100 cigarettes, has smoked daily for at least the past 3 months, now smokes at least 5 cigarettes per day)
  • ST USERS ONLY: Established moist snuff user (has used moist snuff daily for at least the past 3 months, uses at least 1.5 cans/week (as in Pickworth et al., 2014)

Exclusion Criteria:

  • Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
  • History of cardiac event or distress within the past 3 months
  • Currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each Phase 1 study visit \[acute use of usual product and study ONPs\] and Phase 2 study visit 1 \[distribution of study ONPs for outpatient ad libitum use\])
  • Currently engaging in tobacco quit attempt, interested in quitting all tobacco, or planning on quitting all tobacco in the next 3 months
  • Oral or systemic health issues that affect oral microbiome or epithelium, including having fewer than 21 teeth, diabetes mellitus, or autoimmune disease (e.g., rheumatoid arthritis, lupus)
  • CIGARETTE SMOKERS ONLY: Use of non-cigarette tobacco products ≥ 10 of the past 30 days
  • CIGARETTE SMOKERS ONLY: Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease
  • CIGARETTE SMOKERS ONLY: Roll-your-own cigarette smokers
  • ST USERS ONLY: Use of non-moist-snuff tobacco products ≥ 10 of the past 30 days

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PHASE I ARM I (low FBN R/S ONP)

Participants insert low free-base nicotine (FBN) R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.

experimental: PHASE I ARM II (low FBN > 99% S ONP)

Participants insert low FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.

experimental: PHASE I ARM III (high FBN R/S ONP)

Participants insert high R/S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.

experimental: PHASE I ARM IV (high FBN > 99% ONP)

Participants insert high FBN > 99% S ONP product over 30 minutes and insert usual brand of ST over 30 minutes or smoke usual brand of cigarette over 5 minutes during each study visit for 5 visits over up to 3 months. Patients also undergo blood sample collection throughout study.

experimental: PHASE I ARM V (Usual brand ST or cigarette)

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.

experimental: PHASE II ARM I (low FBN R/S ONP)

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.

Participants insert low FBN R/S ONP for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.

experimental: PHASE II ARM II (low FBN > 99% S ONP)

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.

Participants insert to low FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.

experimental: PHASE II ARM III (high R/S ONP)

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.

Participants insert to high R/S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.

experimental: PHASE II ARM IV (high FBN > 99% ONP)

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.

Participants insert high FBN > 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.

Interventions

Biospecimen Collection

Undergo blood sample and oral mucosa sample collection

Cigarette

Smoke usual brand cigarette

Nicotine Oral Pouch

Insert low FBN R/S ONP

Nicotine Oral Pouch

Insert low FBN > 99% S ONP

Nicotine Oral Pouch

Insert high R/S ONP

Nicotine Oral Pouch

Insert high FBN > 99% ONP

Smokeless Tobacco

Insert ST

Survey Administration

Ancillary studies

Text Message-Based Navigation Intervention

Receive text with a link to daily diary surveys

Primary outcome measure

  • Increased nicotine delivery [ Time Frame: Up to 3 months ]
  • Liking [ Time Frame: Up to 3 months ]
  • Craving/withdrawal suppression [ Time Frame: Up to 3 months ]
  • Rate of switching to ONP [ Time Frame: Up to 3 months ]
  • Rate of switching to ONPs [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Brittney L. Keller-Hamilton, PhD, MPH

614-366-9652brittney.keller-hamilton@osumc.edu

Principal Investigator:

Brittney L. Keller-Hamilton, PhD, MPH

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-08-17.