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Tobacco-Related CarcinomaPhase 2NCT06315881

Informing Oral Nicotine Pouch Regulations to Promote Public Health

A Phase 2 study testing Biospecimen Collection, Cigarette and Nicotine Oral Pouch in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Tobacco-Related Carcinoma
What is being tested?
Biospecimen Collection, Cigarette and Nicotine Oral Pouch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
13 Jan 2025to 31 Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Brittney L. Keller-Hamilton, PhD, MPH, 614-366-9652, brittney.keller-hamilton@osumc.edu

    Brittney L. Keller-Hamilton, PhD, MPH

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Cigarette, Nicotine Oral Pouch, Smokeless Tobacco, Survey Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample and oral mucosa sample collection

  • CigaretteDrug

    Smoke usual brand cigarette

  • Nicotine Oral PouchDrug

    Also called ZYN

    Insert low FBN R/S ONP

  • Nicotine Oral PouchDrug

    Also called ZYN

    Insert low FBN > 99% S ONP

  • Nicotine Oral PouchDrug

    Also called ZYN

    Insert high R/S ONP

  • Nicotine Oral PouchDrug

    Also called ZYN

    Insert high FBN > 99% ONP

  • Smokeless TobaccoDrug

    Also called Smoking, Tobacco and Cancer - Smokeless Tobacco

    Insert ST

  • Survey AdministrationOther

    Ancillary studies

  • Text Message-Based Navigation InterventionOther

    Also called Automated Text Message-Based Navigation, Text Message-Based Navigation

    Receive text with a link to daily diary surveys

Study groups in NCT06315881
Study groupRoleWhat they receive
PHASE I ARM I (low FBN R/S ONP)ExperimentalParticipants 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.
Receives: Procedure: Biospecimen Collection; Drug: Cigarette; Drug: Nicotine Oral Pouch; Drug: Smokeless Tobacco; Other: Survey Administration
PHASE I ARM II (low FBN > 99% S ONP)ExperimentalParticipants 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.
Receives: Procedure: Biospecimen Collection; Drug: Cigarette; Drug: Nicotine Oral Pouch; Drug: Smokeless Tobacco; Other: Survey Administration
PHASE I ARM III (high FBN R/S ONP)ExperimentalParticipants 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.
Receives: Procedure: Biospecimen Collection; Drug: Cigarette; Drug: Nicotine Oral Pouch; Drug: Smokeless Tobacco; Other: Survey Administration
PHASE I ARM IV (high FBN > 99% ONP)ExperimentalParticipants 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.
Receives: Procedure: Biospecimen Collection; Drug: Cigarette; Drug: Nicotine Oral Pouch; Drug: Smokeless Tobacco; Other: Survey Administration
PHASE I ARM V (Usual brand ST or cigarette)ExperimentalParticipants 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.
Receives: Procedure: Biospecimen Collection; Drug: Cigarette; Drug: Smokeless Tobacco; Other: Survey Administration
PHASE II ARM I (low FBN R/S ONP)ExperimentalWASHOUT 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.
Receives: Procedure: Biospecimen Collection; Drug: Cigarette; Drug: Nicotine Oral Pouch; Drug: Smokeless Tobacco; Other: Survey Administration; Other: Text Message-Based Navigation Intervention
PHASE II ARM II (low FBN > 99% S ONP)ExperimentalWASHOUT 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.
Receives: Procedure: Biospecimen Collection; Drug: Cigarette; Drug: Nicotine Oral Pouch; Drug: Smokeless Tobacco; Other: Survey Administration; Other: Text Message-Based Navigation Intervention
PHASE II ARM III (high R/S ONP)ExperimentalWASHOUT 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.
Receives: Procedure: Biospecimen Collection; Drug: Cigarette; Drug: Nicotine Oral Pouch; Drug: Smokeless Tobacco; Other: Survey Administration; Other: Text Message-Based Navigation Intervention
PHASE II ARM IV (high FBN > 99% ONP)ExperimentalWASHOUT 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.
Receives: Procedure: Biospecimen Collection; Drug: Cigarette; Drug: Nicotine Oral Pouch; Drug: Smokeless Tobacco; Other: Survey Administration; Other: Text Message-Based Navigation Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increased nicotine delivery

    Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of oral nicotine pouches (ONPs) relative to cigarettes and smokeless tobacco (ST). Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.

    Measured: Up to 3 months

  2. Liking

    Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.

    Measured: Up to 3 months

  3. Craving/withdrawal suppression

    Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.

    Measured: Up to 3 months

  4. Rate of switching to ONP

    Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of ONPs relative to cigarettes and ST. Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.

    Measured: Up to 3 months

  5. Rate of switching to ONPs

    Data will be used to evaluate the effects of nicotine concentration, form and isomer on switching from cigarettes or ST to ONPs either partially or completely. Logistic regression models will be used to examine whether differences in form and isomer significantly impact switching.

    Measured: Up to 3 months

Secondary outcomes (1)

  1. ONP and Tobacco Purchase Task

    Data will be used to assess the prices participants would be willing to pay for each unit of product. Using demand curves generated from self-report data for each product, we will be able to determine how participants' usual brand compares to ONPs at different price points.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start13 Jan 2025
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06315881
Sponsor's protocol ID
OSU-23116
Other IDs
NCI-2024-00666, U54CA287392
Status last verified
Aug 2026
First submitted
14 Feb 2024
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Cigarette and Nicotine Oral Pouch in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increased nicotine delivery (time frame: Up to 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06315881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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