Cigarette Smoking-Related CarcinomaNCT07899827
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
A study testing Biospecimen Collection, Oral nicotine pouches and Survey Administration in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies how different ways of using oral nicotine pouches (ONPs) affect nicotine delivery, appeal, and side effects among adult cigarette smokers. ONPs are tobacco-free nicotine products that contain nicotine but no tobacco leaf and are used by placing them between the lip and gum. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Biospecimen Collection, Oral nicotine pouches and Survey Administration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2027to 31 Dec 2028
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Read and speak English
- At least 21 years old
- Established cigarette smoker, defined as having smoked at least 100 lifetime cigarettes and smoking at least 5 cigarettes per day for at least the past year, and have a baseline expired carbon monoxide (eCO) of 7ppm or higher at visit 1
- Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to study visits
- Willing to attend all study visits and use study ONPs
- Owns a smartphone and is able to receive short message service (SMS) text messages with embedded survey links for daily diary surveys
- Willing to provide a urine sample
- Willing to provide blood samples during the study
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
- History of uncontrolled blood pressure or shortness of breath in the past 3 months
- Currently experiencing problems with irregular heartbeat or abnormal heart rhythm that requires medication
- Currently pregnant, planning to become pregnant, or breastfeeding. Pregnancy status will be verified with urine pregnancy testing before clinic visits when applicable
- Engaged in a quit smoking attempt in the prior two weeks
Show all 11Show fewer
- Currently engaging in a tobacco quit attempt, interested in quitting all tobacco, or planning to quit all tobacco in the next 2 months
- Oral health issues that would affect use of an ONP in the upper or lower lip for 30 minutes
- History of weekly ONP use for 3 months or longer
- Any ONP use in the past 3 months
- History of problematic blood draws
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
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Brittney L. Keller-Hamilton, PhD, MPH, 614-366-9652, keller-hamilton.1@osu.edu
Brittney L. Keller-Hamilton, PhD, MPH
About this study
Official title: The Place Study: Exploring the Effects of Oral Nicotine Pouch Use Topography on Measured Abuse Liability and Adverse Effects
This clinical trial studies how different ways of using oral nicotine pouches (ONPs) affect nicotine delivery, appeal, and side effects among adult cigarette smokers. ONPs are tobacco-free nicotine products that contain nicotine but no tobacco leaf and are used by placing them between the lip and gum. Because ONPs are not burned and do not contain tobacco leaf, they are being studied as a replacement for tobacco products to lower harmful effects, particularly among adult cigarette smokers. However, previous research on ONP use has often been done via controlled assessments which had users place them in one area of the mouth, which does not reflect how they are used in the real-world. Researchers believe this approach leaves gaps in knowledge on how nicotine is delivered, sensory effects, craving and withdrawal, appeal, and side effects. This trial will have participants use ONPs in different ways, such as placed between the upper lip and gum, placed between the lower lip and gum, and placing them however they would like. Researchers hope that by studying these different use patterns they will understand more about how they affect nicotine delivery, appeal, and side effects among adult cigarette smokers.
Read the detailed description
PRIMARY OBJECTIVES:
- Quantify the effects of ONP use topography on objective and subjective measures of ONP abuse liability.
II. Examine associations between ONP use topography and adverse effects during and after ONP use.
SECONDARY OBJECTIVES:
- Describe and code ad libitum ONP use behaviors using video recordings and self-report measures.
II. Explore whether specific ad libitum use behaviors, such as movement of the pouch, spitting, squeezing, biting, or placement location, are associated with differences in abuse liability or adverse effects.
III. Explore heterogeneity of condition effects by sex, as cell sizes permit.
OUTLINE:
SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. Participants are then randomized to 1 of 6 condition orders.
CONDITION ORDER 1: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the upper lip and gum; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the lower lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes however they would like (ad libitum use). Additionally, patients undergo blood sample collection on study.
CONDITION ORDER 2: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the upper lip and gum; Laboratory visit 2) Participants use study ONP with ad libitum use for 30 minutes; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the lower lip and gum. Additionally, patients undergo blood sample collection on study.
CONDITION ORDER 3: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the lower lip and gum; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the upper lip and gum; and Laboratory visit 3) Participants use study ONP with ad libitum use for 30 minutes. Additionally, patients undergo blood sample collection on study.
CONDITION ORDER 4: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the lower lip and gum; Laboratory visit 2) Participants use study ONP with ad libitum use for 30 minutes; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the upper lip and gum. Additionally, patients undergo blood sample collection on study.
CONDITION ORDER 5: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP with ad libitum use for 30 minutes; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the upper lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the lower lip and gum. Additionally, patients undergo blood sample collection on study.
CONDITION ORDER 6: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP with ad libitum use for 30 minutes; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the lower lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the upper lip and gum. Additionally, patients undergo blood sample collection on study.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Biospecimen Collection, Oral nicotine pouches, 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, Sample Collection, Specimen Collection
Undergo blood sample collection
Oral nicotine pouchesDrug
Also called ZYN, ONPs
Complete at-home sampling of ONPs
Oral nicotine pouchesDrug
Also called ONPs, ZYN
Use ONP with upper lip and gum placement
Oral nicotine pouchesDrug
Also called ONPs, ZYN
Use ONP with lower lip and gum placement
Oral nicotine pouchesDrug
Also called ONPs, ZYN
Use ONP with ad libitum use
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Condition Order 1 (upper lip, lower lip, ad libitum) | Experimental | SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity.
CONDITION ORDER 1: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the upper lip and gum; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the lower lip and gum; and Laboratory visit 3) Participants use study ONP with ad libitum use for 30 minutes. Additionally, patients undergo blood sample collection on study. Receives: Procedure: Biospecimen Collection; Drug: Oral nicotine pouches; Other: Survey Administration |
| Condition Order 2 (upper lip, ad libitum, lower lip) | Experimental | SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity.
CONDITION ORDER 2: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the upper lip and gum; Laboratory visit 2) Participants use study ONP with ad libitum use for 30 minutes; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the lower lip and gum. Additionally, patients undergo blood sample collection on study. Receives: Procedure: Biospecimen Collection; Drug: Oral nicotine pouches; Other: Survey Administration |
| Condition Order 3 (lower lip, upper lip, ad libitum) | Experimental | SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity.
CONDITION ORDER 3: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the lower lip and gum; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the upper lip and gum; and Laboratory visit 3) Participants use study ONP with ad libitum use for 30 minutes. Additionally, patients undergo blood sample collection on study. Receives: Procedure: Biospecimen Collection; Drug: Oral nicotine pouches; Other: Survey Administration |
| Condition Order 4 (lower lip, ad libitum, upper lip) | Experimental | SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity.
CONDITION ORDER 4: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the lower lip and gum; Laboratory visit 2) Participants use study ONP with ad libitum use for 30 minutes; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the upper lip and gum. Additionally, patients undergo blood sample collection on study. Receives: Procedure: Biospecimen Collection; Drug: Oral nicotine pouches; Other: Survey Administration |
| Condition Order 5 (ad libitum, upper lip, lower lip) | Experimental | SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity.
CONDITION ORDER 5: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP with ad libitum use for 30 minutes; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the upper lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the lower lip and gum. Additionally, patients undergo blood sample collection on study. Receives: Procedure: Biospecimen Collection; Drug: Oral nicotine pouches; Other: Survey Administration |
| Condition Order 6 (ad libitum, lower lip, upper lip) | Experimental | SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity.
CONDITION ORDER 6: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP with ad libitum use for 30 minutes; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the lower lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the upper lip and gum. Additionally, patients undergo blood sample collection on study. Receives: Procedure: Biospecimen Collection; Drug: Oral nicotine pouches; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Nicotine Pharmacokinetics (Cmax)
The maximum nicotine concentration observed in the plasma samples for each participant.
Measured: At laboratory visits 2, 3, and 4, assessed up to 1 month
Plasma Nicotine Pharmacokinetics (Tmax)
The time at which the maximum nicotine concentration is observed in the plasma samples for each participant.
Measured: At laboratory visits 2, 3, and 4, assessed up to 1 month
Plasma Nicotine Pharmacokinetics (AUC_0-90)
Area under the curve (AUC) of plasma nicotine levels from minute 0 to 90 for each participant.
Measured: At laboratory visits 2, 3, and 4, assessed up to 1 month
Product Liking
Participants will rate appeal (e.g., liking, disliking) on Visual Analogue Scales (range, 0-100). Higher scores indicate a greater degree of liking/disliking.
Measured: At laboratory visits 2, 3, and 4, assessed up to 1 month
Product Appeal (mCEQ)
12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following ONP self-administration to assess subjective responses to the ONPs. The 12-item mCEQ includes five subscales: Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale.
Measured: At laboratory visits 2, 3, and 4, assessed up to 1 month
Behavioral Economic Demand
After product use, participants will complete a purchase task to assess demand indices including demand elasticity.
Measured: At laboratory visits 2, 3, and 4, assessed up to 1 month
Craving Relief (QSU)
Urges/craving will be measured using a modified version of the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU). This is a 10-item measure where participants rate items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, the investigators will collapse the items into two previously identified factors (Factor 1: strong desire and intention to use; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving.
Measured: At laboratory visits 2, 3, and 4, assessed up to 1 month
Relief of Withdrawal Symptoms (MNWS)
Nicotine withdrawal relief will be measured by the Minnesota Nicotine Withdraw Scale (MNWS). The MNWS asks users how much they are currently feeling certain nicotine withdraw symptoms on a scale of None (0), Slight, Moderate, Mild, or Severe (4).
This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 8 items with scores ranging from 0 to 32 .
Measured: At laboratory visits 2, 3, and 4, assessed up to 1 month
Intensity of Sensory Attributes (gLMS)
5-item self-report measure completed following ONP administration, using the general Labeled Magnitude Scale (gLMS). Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.
Measured: At laboratory visits 2, 3, and 4, assessed up to 1 month
Behavioral Intentions
Intentions to use the product again using the respective topography, purchase the product for personal use if required to use the topography, and use the product regularly following the topography. Self-report measure on a 7-point scale. Ratings range from 1 (extremely unlikely) to 7 (extremely likely) with higher scores indicating a higher likelihood of continuing to use the product.
Measured: At laboratory visits 2, 3, and 4, assessed up to 1 month
Incidence of Adverse Effects
Adverse effects of interest include hiccups, headache, stinging or irritated gums, dry mouth, excess saliva, mouth sores or inflammation, cough, dizziness, sleepiness, and other participant-reported symptoms.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start2 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Brittney Keller-Hamilton, Ohio State University Comprehensive Cancer Center
- Investigators
- Brittney L Keller-Hamilton, PhD, MPH, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899827
- Sponsor's protocol ID
- OSU-26229
- Other IDs
- NCI-2026-07165, STUDY20261669, R21DA067197
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data from self-report measures will be deposited in the Inter-university Consortium for Political and Social Research (ICPSR). ICPSR will make the research data from this project available to the broader social science research community as public-use data files. These files, in which direct and indirect identifiers have been removed to minimize disclosure risk, may be accessed directly through the ICPSR website.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Place Study: Exploring the Effects of Oral Nicotine Pouch Use Topography on Measured Abuse Liability and Adverse Effects
- ClinicalTrials.gov ID
- NCT07899827
- Acronym / sponsor ID
- OSU-26229
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies how different ways of using oral nicotine pouches (ONPs) affect nicotine delivery, appeal, and side effects among adult cigarette smokers. ONPs are tobacco-free nicotine products that contain nicotine but no tobacco leaf and are used by placing them between the lip and gum. Because ONPs are not burned and do not contain tobacco leaf, they are being studied as a replacement for tobacco products to lower harmful effects, particularly among adult cigarette smokers. However, previous research on ONP use has often been done via controlled assessments which had users place them in one area of the mouth, which does not reflect how they are used in the real-world. Researchers believe this approach leaves gaps in knowledge on how nicotine is delivered, sensory effects, craving and withdrawal, appeal, and side effects. This trial will have participants use ONPs in different ways, such as placed between the upper lip and gum, placed between the lower lip and gum, and placing them however they would like. Researchers hope that by studying these different use patterns they will understand more about how they affect nicotine delivery, appeal, and side effects among adult cigarette smokers.
Detailed description
PRIMARY OBJECTIVES:
- Quantify the effects of ONP use topography on objective and subjective measures of ONP abuse liability.
II. Examine associations between ONP use topography and adverse effects during and after ONP use.
SECONDARY OBJECTIVES:
- Describe and code ad libitum ONP use behaviors using video recordings and self-report measures.
II. Explore whether specific ad libitum use behaviors, such as movement of the pouch, spitting, squeezing, biting, or placement location, are associated with differences in abuse liability or adverse effects.
III. Explore heterogeneity of condition effects by sex, as cell sizes permit.
OUTLINE:
SAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. Participants are then randomized to 1 of 6 condition orders.
CONDITION ORDER 1: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the upper lip and gum; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the lower lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes however they would like (ad libitum use). Additionally, patients undergo blood sample collection on study.
CONDITION ORDER 2: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the upper lip and gum; Laboratory visit 2) Participants use study ONP with ad libitum use for 30 minutes; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the lower lip and gum. Additionally, patients undergo blood sample collection on study.
CONDITION ORDER 3: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the lower lip and gum; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the upper lip and gum; and Laboratory visit 3) Participants use study ONP with ad libitum use for 30 minutes. Additionally, patients undergo blood sample collection on study.
CONDITION ORDER 4: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the lower lip and gum; Laboratory visit 2) Participants use study ONP with ad libitum use for 30 minutes; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the upper lip and gum. Additionally, patients undergo blood sample collection on study.
CONDITION ORDER 5: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP with ad libitum use for 30 minutes; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the upper lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the lower lip and gum. Additionally, patients undergo blood sample collection on study.
CONDITION ORDER 6: Following at-home sampling week, participants attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP with ad libitum use for 30 minutes; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the lower lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the upper lip and gum. Additionally, patients undergo blood sample collection on study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Condition Order 1 (upper lip, lower lip, ad libitum) | Experimental | Procedure: Biospecimen Collection, Drug: Oral nicotine pouches, Other: Survey AdministrationSAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 1: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the upper lip and gum; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the lower lip and gum; and Laboratory visit 3) Participants use study ONP with ad libitum use for 30 minutes. Additionally, patients undergo blood sample collection on study. |
| Condition Order 2 (upper lip, ad libitum, lower lip) | Experimental | Procedure: Biospecimen Collection, Drug: Oral nicotine pouches, Other: Survey AdministrationSAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 2: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the upper lip and gum; Laboratory visit 2) Participants use study ONP with ad libitum use for 30 minutes; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the lower lip and gum. Additionally, patients undergo blood sample collection on study. |
| Condition Order 3 (lower lip, upper lip, ad libitum) | Experimental | Procedure: Biospecimen Collection, Drug: Oral nicotine pouches, Other: Survey AdministrationSAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 3: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the lower lip and gum; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the upper lip and gum; and Laboratory visit 3) Participants use study ONP with ad libitum use for 30 minutes. Additionally, patients undergo blood sample collection on study. |
| Condition Order 4 (lower lip, ad libitum, upper lip) | Experimental | Procedure: Biospecimen Collection, Drug: Oral nicotine pouches, Other: Survey AdministrationSAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 4: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP for 30 minutes with placement between the lower lip and gum; Laboratory visit 2) Participants use study ONP with ad libitum use for 30 minutes; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the upper lip and gum. Additionally, patients undergo blood sample collection on study. |
| Condition Order 5 (ad libitum, upper lip, lower lip) | Experimental | Procedure: Biospecimen Collection, Drug: Oral nicotine pouches, Other: Survey AdministrationSAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 5: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP with ad libitum use for 30 minutes; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the upper lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the lower lip and gum. Additionally, patients undergo blood sample collection on study. |
| Condition Order 6 (ad libitum, lower lip, upper lip) | Experimental | Procedure: Biospecimen Collection, Drug: Oral nicotine pouches, Other: Survey AdministrationSAMPLING WEEK: Participants receive study ONP and complete at-home sampling of ONPs for 1 week in the absence of unacceptable toxicity. CONDITION ORDER 6: Following at-home sampling week, participants then attend three laboratory visits in the absence of unacceptable toxicity which consist of the following: Laboratory visit 1) Participants use study ONP with ad libitum use for 30 minutes; Laboratory visit 2) Participants use study ONP for 30 minutes with placement between the lower lip and gum; and Laboratory visit 3) Participants use study ONP for 30 minutes with placement between the upper lip and gum. Additionally, patients undergo blood sample collection on study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Read and speak English
- At least 21 years old
- Established cigarette smoker, defined as having smoked at least 100 lifetime cigarettes and smoking at least 5 cigarettes per day for at least the past year, and have a baseline expired carbon monoxide (eCO) of 7ppm or higher at visit 1
- Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to study visits
- Willing to attend all study visits and use study ONPs
Key exclusion criteria (11 listed)
- Unstable or significant psychiatric conditions; past and stable conditions will be allowed
- History of cardiac event or distress within the past 3 months
- History of uncontrolled blood pressure or shortness of breath in the past 3 months
- Currently experiencing problems with irregular heartbeat or abnormal heart rhythm that requires medication
- Currently pregnant, planning to become pregnant, or breastfeeding. Pregnancy status will be verified with urine pregnancy testing before clinic visits when applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Condition Order 1 (upper lip, lower lip, ad libitum), Condition Order 2 (upper lip, ad libitum, lower lip), Condition Order 3 (lower lip, upper lip, ad libitum), Condition Order 4 (lower lip, ad libitum, upper lip), Condition Order 5 (ad libitum, upper lip, lower lip), Condition Order 6 (ad libitum, lower lip, upper lip) |
| Oral nicotine pouchesAlso: ZYN, ONPsComplete at-home sampling of ONPs | Drug | Condition Order 1 (upper lip, lower lip, ad libitum), Condition Order 2 (upper lip, ad libitum, lower lip), Condition Order 3 (lower lip, upper lip, ad libitum), Condition Order 4 (lower lip, ad libitum, upper lip), Condition Order 5 (ad libitum, upper lip, lower lip), Condition Order 6 (ad libitum, lower lip, upper lip) |
| Oral nicotine pouchesAlso: ONPs, ZYNUse ONP with upper lip and gum placement | Drug | Condition Order 1 (upper lip, lower lip, ad libitum), Condition Order 2 (upper lip, ad libitum, lower lip), Condition Order 3 (lower lip, upper lip, ad libitum), Condition Order 4 (lower lip, ad libitum, upper lip), Condition Order 5 (ad libitum, upper lip, lower lip), Condition Order 6 (ad libitum, lower lip, upper lip) |
| Oral nicotine pouchesAlso: ONPs, ZYNUse ONP with lower lip and gum placement | Drug | Condition Order 1 (upper lip, lower lip, ad libitum), Condition Order 2 (upper lip, ad libitum, lower lip), Condition Order 3 (lower lip, upper lip, ad libitum), Condition Order 4 (lower lip, ad libitum, upper lip), Condition Order 5 (ad libitum, upper lip, lower lip), Condition Order 6 (ad libitum, lower lip, upper lip) |
| Oral nicotine pouchesAlso: ONPs, ZYNUse ONP with ad libitum use | Drug | Condition Order 1 (upper lip, lower lip, ad libitum), Condition Order 2 (upper lip, ad libitum, lower lip), Condition Order 3 (lower lip, upper lip, ad libitum), Condition Order 4 (lower lip, ad libitum, upper lip), Condition Order 5 (ad libitum, upper lip, lower lip), Condition Order 6 (ad libitum, lower lip, upper lip) |
| Survey AdministrationAncillary studies | Other | Condition Order 1 (upper lip, lower lip, ad libitum), Condition Order 2 (upper lip, ad libitum, lower lip), Condition Order 3 (lower lip, upper lip, ad libitum), Condition Order 4 (lower lip, ad libitum, upper lip), Condition Order 5 (ad libitum, upper lip, lower lip), Condition Order 6 (ad libitum, lower lip, upper lip) |
Primary outcome
Plasma Nicotine Pharmacokinetics (Cmax)
Time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month
The maximum nicotine concentration observed in the plasma samples for each participant.
Plasma Nicotine Pharmacokinetics (Tmax)
Time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month
The time at which the maximum nicotine concentration is observed in the plasma samples for each participant.
Plasma Nicotine Pharmacokinetics (AUC_0-90)
Time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month
Area under the curve (AUC) of plasma nicotine levels from minute 0 to 90 for each participant.
Product Liking
Time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month
Participants will rate appeal (e.g., liking, disliking) on Visual Analogue Scales (range, 0-100). Higher scores indicate a greater degree of liking/disliking.
Product Appeal (mCEQ)
Time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month
12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following ONP self-administration to assess subjective responses to the ONPs. The 12-item mCEQ includes five subscales: Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale.
Behavioral Economic Demand
Time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month
After product use, participants will complete a purchase task to assess demand indices including demand elasticity.
Craving Relief (QSU)
Time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month
Urges/craving will be measured using a modified version of the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU). This is a 10-item measure where participants rate items on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, the investigators will collapse the items into two previously identified factors (Factor 1: strong desire and intention to use; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving.
Relief of Withdrawal Symptoms (MNWS)
Time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month
Nicotine withdrawal relief will be measured by the Minnesota Nicotine Withdraw Scale (MNWS). The MNWS asks users how much they are currently feeling certain nicotine withdraw symptoms on a scale of None (0), Slight, Moderate, Mild, or Severe (4). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 8 items with scores ranging from 0 to 32 .
Intensity of Sensory Attributes (gLMS)
Time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month
5-item self-report measure completed following ONP administration, using the general Labeled Magnitude Scale (gLMS). Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.
Behavioral Intentions
Time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month
Intentions to use the product again using the respective topography, purchase the product for personal use if required to use the topography, and use the product regularly following the topography. Self-report measure on a 7-point scale. Ratings range from 1 (extremely unlikely) to 7 (extremely likely) with higher scores indicating a higher likelihood of continuing to use the product.
Incidence of Adverse Effects
Time frame: Up to 1 month
Adverse effects of interest include hiccups, headache, stinging or irritated gums, dry mouth, excess saliva, mouth sores or inflammation, cough, dizziness, sleepiness, and other participant-reported symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data from self-report measures will be deposited in the Inter-university Consortium for Political and Social Research (ICPSR). ICPSR will make the research data from this project available to the broader social science research community as public-use data files. These files, in which direct and indirect identifiers have been removed to minimize disclosure risk, may be accessed directly through the ICPSR website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Brittney L Keller-Hamilton, PhD, MPH principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Oral nicotine pouches and Survey Administration in people with Cigarette Smoking-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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 28 Oct 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.
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?
Plasma Nicotine Pharmacokinetics (Cmax) (time frame: At laboratory visits 2, 3, and 4, assessed up to 1 month). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.