An interventional study of Biospecimen Collection and Oral nicotine pouches in Cigarette Smoking-Related Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.
This study's planned enrollment of 50 is below the median of 96 across 406 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 377 studies on the registry; 84 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Biospecimen Collection · Drug: Oral nicotine pouches · Other: Survey Administration
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.
Procedure: Biospecimen Collection · Drug: Oral nicotine pouches · Other: Survey Administration
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.
Procedure: Biospecimen Collection · Drug: Oral nicotine pouches · Other: Survey Administration
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.
Procedure: Biospecimen Collection · Drug: Oral nicotine pouches · Other: Survey Administration
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.
Procedure: Biospecimen Collection · Drug: Oral nicotine pouches · Other: Survey Administration
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.
Procedure: Biospecimen Collection · Drug: Oral nicotine pouches · Other: Survey Administration
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Complete at-home sampling of ONPs
Also known as: ZYN, ONPs
Use ONP with upper lip and gum placement
Also known as: ONPs, ZYN
Use ONP with lower lip and gum placement
Also known as: ONPs, ZYN
Use ONP with ad libitum use
Also known as: ONPs, ZYN
Ancillary studies
Plasma Nicotine Pharmacokinetics (Cmax)
The maximum nicotine concentration observed in the plasma samples for each participant.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 month
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The research data from this project will be supplied to ICPSR at the time of publication of the relevant results or at the end of the project period, whichever is sooner, so that any issues surrounding the usability of the data can be resolved. Delayed dissemination may be possible. The Delayed Dissemination Policy allows for data to be deposited but not disseminated for an agreed-upon period (typically one year).
Access criteria: After agreeing to Terms of Use, users with an ICPSR MyData account and an authorized IP address from a member institution may download the data, and non-members may purchase the files.
Start is estimated for Jan 2027; primary completion for Dec 2027, 11 months later.
Of 184 non-industry interventional studies with no phase under Cigarette Smoking, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 33. This study's planned 11 months is below that.
Counting every sponsor, half of 191 studies reached it within 20 months; a quarter within 9 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nicotine Oral Pouch
Ohio State University Comprehensive Cancer Center →