Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
The Place Study: Exploring the Effects of Oral Nicotine Pouch Use Topography on Measured Abuse Liability and Adverse Effects
Other study identifiers
Sponsor study identifier
Secondary identifiers
interventional
50
1 country
1
Study Start
January 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Brief 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. 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- not yet recruiting
- Estimated enrollment
- 50 participants
- Study completion date
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Some registry-reported names shown below are not yet linked in this graph.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
October 20, 2026
Actual (reported)First Posted
October 28, 2026
Actual (reported)Study Start
January 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
- Last Updated
- October 28, 2026
- Status Verified
- October 2026
- Last Update Submitted
- October 20, 2026
Conditions
Outcome Measures
Primary Outcomes (11)
Plasma Nicotine Pharmacokinetics (Cmax)
The maximum nicotine concentration observed in the plasma samples for each participant.
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.
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.
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.
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.
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.
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.
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 .
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.
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.
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.
Up to 1 month
Study Arms (6)
Condition Order 1 (upper lip, lower lip, ad libitum)
EXPERIMENTALSAMPLING 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)
EXPERIMENTALSAMPLING 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)
EXPERIMENTALSAMPLING 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)
EXPERIMENTALSAMPLING 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)
EXPERIMENTALSAMPLING 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)
EXPERIMENTALSAMPLING 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.
Interventions
Undergo blood sample collection
Complete at-home sampling of ONPs
Use ONP with upper lip and gum placement
Use ONP with lower lip and gum placement
Use ONP with ad libitum use
Ancillary studies
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Drug Abuse (NIDA)NIHcollaborator
- Ohio State University Comprehensive Cancer CenterOtherlead
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brittney L Keller-Hamilton, PhD, MPH
Ohio State University Comprehensive Cancer Center
Central Study Contacts
The Ohio State University Comprehensive Cancer Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 20, 2026
First Posted
October 28, 2026
Study Start
January 2, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
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.
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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- Registry identifier
- NCT07899827
- Data provider
- ClinicalTrials.gov
- Source updated
- 2026-10-28
- Normalization version
- ctgov-2
Source retrieved: