What this study is
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.
What's being tested
- Biospecimen Collection
Intervention · PROCEDURE
Undergo blood sample and oral mucosa sample collection
- Cigarette
Intervention · DRUG
Smoke usual brand cigarette
- Nicotine Oral Pouch
Intervention · DRUG
Insert low FBN R/S ONP
- Nicotine Oral Pouch
Intervention · DRUG
Insert low FBN > 99% S ONP
- Nicotine Oral Pouch
Intervention · DRUG
Insert high R/S ONP
- Nicotine Oral Pouch
Intervention · DRUG
Insert high FBN > 99% ONP
- Smokeless Tobacco
Intervention · DRUG
Insert ST
- Survey Administration
Intervention · OTHER
Ancillary studies
- Text Message-Based Navigation Intervention
Intervention · OTHER
Receive text with a link to daily diary surveys
Study details
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Conditions
- Tobacco-Related Carcinoma
- Enrolling
- 160 people
- Starts
- 2025-01-13
- Est. completion
- 2028-08-31
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openOhio State University Comprehensive Cancer Center
Columbus, Ohio, United States
- Brittney L. Keller-Hamilton, PhD, MPH · Contact614-366-9652brittney.keller-hamilton@osumc.edu
- Brittney L. Keller-Hamilton, PhD, MPH · Principal investigator
Recruiting
Study team
Sponsor
Ohio State University Comprehensive Cancer Center
Study ID OSU-23116
Principal investigator
Brittney L Keller-Hamilton, PhD, MPH
Ohio State University Comprehensive Cancer Center
CONTACT
The Ohio State University Comprehensive Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.