Informing Oral Nicotine Pouch Regulations to Promote Public Health
NCT ID: NCT06315881
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2025-01-13
2028-08-31
Brief Summary
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Detailed Description
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I. Assess the effects of nicotine concentration, form, and isomer on the satisfaction and appeal of ONPs relative to cigarettes and ST.
II. Evaluate the effects of nicotine concentration, form, and isomer on switching from cigarettes or ST to ONPs.
EXPLORATORY OBJECTIVE:
I. Examine changes in oral microbiome-host interactions associated with degree of switching from cigarettes/ST to ONPs.
OUTLINE:
PHASE I: Participants are randomized to use one of the 4 study ONP products or their usual product brand of ST or cigarette in either the low or high nicotine concentration arm.
ARM I: Participants insert low free-base nicotine (FBN) R/S ONP product over 30 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes.
ARM II: Participants insert low FBN \> 99% S ONP product over 30 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes.
ARM III: Participants insert high R/S ONP product over 30 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes.
ARM IV: Participants insert high FBN \> 99% S ONP product over 30 minutes. Patients also undergo blood sample collection at 0, 5, 15, 30, 60, and 90 minutes.
ARM V: 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.
PHASE II:
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.
PHASE II SWITCH: Participants are randomized to switch to 1 of 4 study ONP.
ARM I: Participants insert low FBN R/S ONP for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
ARM II: Participants insert to low FBN \> 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
ARM III: Participants insert to high R/S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
ARM IV: Participants insert high FBN \> 99% S ONP product for 4 weeks. Participants also attend 2 study visits and undergo oral mucosa sample collection.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
Cigarette
Smoke usual brand cigarette
Nicotine Oral Pouch
Insert low FBN R/S ONP
Smokeless Tobacco
Insert ST
Survey Administration
Ancillary studies
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.
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
Cigarette
Smoke usual brand cigarette
Nicotine Oral Pouch
Insert low FBN \> 99% S ONP
Smokeless Tobacco
Insert ST
Survey Administration
Ancillary studies
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.
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
Cigarette
Smoke usual brand cigarette
Nicotine Oral Pouch
Insert high R/S ONP
Smokeless Tobacco
Insert ST
Survey Administration
Ancillary studies
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.
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
Cigarette
Smoke usual brand cigarette
Nicotine Oral Pouch
Insert high FBN \> 99% ONP
Smokeless Tobacco
Insert ST
Survey Administration
Ancillary studies
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.
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
Cigarette
Smoke usual brand cigarette
Smokeless Tobacco
Insert ST
Survey Administration
Ancillary studies
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.
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
Cigarette
Smoke usual brand cigarette
Nicotine Oral Pouch
Insert low FBN R/S ONP
Smokeless Tobacco
Insert ST
Survey Administration
Ancillary studies
Text Message-Based Navigation Intervention
Receive text with a link to daily diary surveys
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.
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
Cigarette
Smoke usual brand cigarette
Nicotine Oral Pouch
Insert low FBN \> 99% S ONP
Smokeless Tobacco
Insert ST
Survey Administration
Ancillary studies
Text Message-Based Navigation Intervention
Receive text with a link to daily diary surveys
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.
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
Cigarette
Smoke usual brand cigarette
Nicotine Oral Pouch
Insert high R/S ONP
Smokeless Tobacco
Insert ST
Survey Administration
Ancillary studies
Text Message-Based Navigation Intervention
Receive text with a link to daily diary surveys
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.
Biospecimen Collection
Undergo blood sample and oral mucosa sample collection
Cigarette
Smoke usual brand cigarette
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Brittney Keller-Hamilton
Principal Investigator
Principal Investigators
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Brittney L Keller-Hamilton, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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The Jamesline
Other Identifiers
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NCI-2024-00666
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-23116
Identifier Type: -
Identifier Source: org_study_id
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