Tobacco-Related CarcinomaPhase 4THRIVENCT07503925
THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health
A Phase 4 study testing Biospecimen Collection, Nicotine Oral Pouch and Survey Administration in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
Although nicotine pouches have been gaining popularity over the last few years, little known about how nicotine pouch users actually use these products. This study will be comprised of adults who use nicotine pouches. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco-Related Carcinoma
- What is being tested?
- Biospecimen Collection, Nicotine Oral Pouch 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2026to 31 Dec 2027
- Phase
- Phase 4
- 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
- Age 21 or older
- Able to read and speak English
- Willing to abstain from tobacco, nicotine, and marijuana for at least 12 hours prior to study visits
- Exclusive use of ONPs (other product use <10x/mo).
- Exhaled CO reading <10 ppm
- Owns a smartphone and can receive SMS text messages with embedded survey links
Show all 10Show fewer
- Negative pregnancy test at V1 and V2 (if applicable)
- Uses ≥1.5 cans of ONPs/week
- Daily use of ONPs for the past 3 months
- At least half of ONPs used are 6mg nicotine concentration.
Who cannot join
- Non-English speaker
- Individuals currently pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks associated with nicotine exposure and study procedures (e.g., blood draws).
- Individuals with unstable or significant psychiatric conditions are excluded to minimize risk and ensure reliable participation.
- Individuals actively attempting to quit nicotine use are excluded to avoid ethical concerns and ensure that study participation does not interfere with cessation efforts
- Non-nicotine users and regular tobacco users are excluded from the clinical trial component to ensure that participants have established use patterns appropriate for assessing ONP use behaviors.
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, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Brittney L. Keller-Hamilton, PhD, MPH
About this study
Official title: THRIVE Study: Informing Oral Nicotine Pouch Regulations to Promote Public Health
Although nicotine pouches have been gaining popularity over the last few years, little known about how nicotine pouch users actually use these products.
This study will be comprised of adults who use nicotine pouches. If eligible, participants will be asked to complete three study visits and participate in two switching periods where participants use study-provided nicotine pouches.
Read the detailed description
This investigation expands on the parent study's Aims 1 and 2 by examining the effects of a feature that the investigators have identified varies across nicotine pouches (ONP): particle size. The investigators expect that particle size differences may translate to differences in user experience. The investigators wish to further explore this hypothesis among current ONP users. Data will be captured over the course of 3 clinic visits and across two week-long switching periods with daily diary surveys. This will inform interpretation of results from Aims 1 and 2, including how to translate those findings to commercially-available nicotine pouches.
Aim 1: Assess the effects of nicotine concentration, form, and isomer on the satisfaction and appeal of ONPs relative to cigarettes and ST. ONPs with high FBN and >99% S-nicotine will have (H1a) increased satisfaction and appeal (e.g., faster nicotine delivery, greater liking). H1b: Associations of form and isomer with addiction potential and appeal will be strongest in the high nicotine concentration arm.
Aim 2: Evaluate the effects of nicotine concentration, form, and isomer on switching from cigarettes or ST to ONPs. Over 4 weeks, participants randomized to use ONPs with high FBN and >99% S-nicotine (vs. other ONPs) will report higher prevalence of (H2a) partially switching to ONPs (use ONPs >14 days but continued usual product use) and (H2b) complete switching to ONPs by week 4. H2c: Associations of form and isomer with switching outcomes will be strongest in the high nicotine concentration arm.
Study Procedures:
Participants will complete three in-person visits. Visits involve randomized, double-blinded use of either small-particle ONPs or a distribution of particle-size ONPs (one assigned product per visit).
Visit 1
- 12-hour abstinence requirement prior to visit.
- Informed consent procedures.
- Baseline questionnaires.
- Exhaled carbon monoxide (CO) testing and pregnancy screening (if applicable).
- IV-line placement followed by four timed blood draws to assess plasma nicotine levels.
- 120-minute controlled ONP use session.
Post-use surveys assessing:
- Product appeal
- Withdrawal symptoms and relief
- Sensory scales
- Behavioral intentions
One-Week Switching Period (at-home)
Following Visit 1, participants enter a 7-day ad libitum use period using their assigned ONPs.
During this phase, participants complete online daily diary surveys (1 per day) to capture product use and switching behavior.
Visit 2
- 12-hour abstinence prior to visit.
- Exhaled CO testing and pregnancy screening (if applicable).
- IV-line placement and four timed blood draws (plasma nicotine levels).
- 120-minute controlled ONP use session.
- Post-use surveys (same as Visit 1).
One-Week Switching Period (at-home)
Following Visit 2, participants enter a 7-day ad libitum use period using their assigned ONPs.
During this phase, participants complete online daily diary surveys (1 per day) to capture product use and switching behavior.
Visit 3
- Completion of survey measures only (no product administration or IV-lines).
- Return of unused ONPs from the at-home switching period.
- Conditions
- Tobacco-Related Carcinoma
- Being tested
- Biospecimen Collection, Nicotine Oral Pouch, Survey Administration, Text Message-Based Navigation Intervention
- Keywords
- Tobacco, Oral Nicotine Pouches, Particle Size, Tobacco Regulation
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
Undergo blood sample collection
Nicotine Oral PouchDrug
Insert small particle size ONP
Nicotine Oral PouchDrug
Insert variable particle size ONP
Survey AdministrationOther
Ancillary studies
Text Message-Based Navigation InterventionOther
Also called Automated Text Message-Based Navigation
Receive text with a link to daily diary surveys
| Study group | Role | What they receive |
|---|---|---|
| Small particle size oral nicotine pouches | Experimental | CLINIC VISIT: Participants sample a small particle size ONP product. Patients also undergo blood sample collection throughout study.
SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior. Receives: Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch; Other: Survey Administration; Other: Text Message-Based Navigation Intervention |
| Variable particle size oral nicotine pouches | Experimental | CLINIC VISIT: Participants sample a variable particle size ONP product. Patients also undergo blood sample collection throughout study.
SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior. Receives: Procedure: Biospecimen Collection; Drug: Nicotine Oral Pouch; 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.
Nicotine Delivery, Cmax
Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.
Measured: 2 weeks
Secondary outcomes (7)
Switching Behavior
Switching behavior will be quantified using the number of days during the switching week that each participant completely switches from their usual ONP to the study product.
Measured: 2 weeks
Nicotine Delivery, Tmax
The time at which the maximum nicotine concentration is observed in the plasma samples for each participant.
Measured: 2 weeks
Nicotine Delivery, AUC
Area under the curve (AUC) of plasma nicotine levels versus time for each participant.
Measured: 2 weeks
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: 2 weeks
Withdrawal, MNWS
The Minnesota Nicotine Withdrawal Scale (MNWS) will asses nicotine withdrawal and craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal.
Measured: 2 weeks
Product Appeal, mCEQ
12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following e-cigarette 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: 2 weeks
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: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start26 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco-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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- NCT07503925
- Sponsor's protocol ID
- OSU-26043
- Acronym
- THRIVE
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THRIVE Study: Informing Oral Nicotine Pouch Regulations to Promote Public Health
- ClinicalTrials.gov ID
- NCT07503925
- Acronym / sponsor ID
- THRIVE / OSU-26043
- Conditions
- Tobacco-Related Carcinoma
- Keywords
- Tobacco, Oral Nicotine Pouches, Particle Size, Tobacco Regulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Mar 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.
Although nicotine pouches have been gaining popularity over the last few years, little known about how nicotine pouch users actually use these products.
This study will be comprised of adults who use nicotine pouches. If eligible, participants will be asked to complete three study visits and participate in two switching periods where participants use study-provided nicotine pouches.
Detailed description
This investigation expands on the parent study's Aims 1 and 2 by examining the effects of a feature that the investigators have identified varies across nicotine pouches (ONP): particle size. The investigators expect that particle size differences may translate to differences in user experience. The investigators wish to further explore this hypothesis among current ONP users. Data will be captured over the course of 3 clinic visits and across two week-long switching periods with daily diary surveys. This will inform interpretation of results from Aims 1 and 2, including how to translate those findings to commercially-available nicotine pouches.
Aim 1: Assess the effects of nicotine concentration, form, and isomer on the satisfaction and appeal of ONPs relative to cigarettes and ST. ONPs with high FBN and >99% S-nicotine will have (H1a) increased satisfaction and appeal (e.g., faster nicotine delivery, greater liking). H1b: Associations of form and isomer with addiction potential and appeal will be strongest in the high nicotine concentration arm.
Aim 2: Evaluate the effects of nicotine concentration, form, and isomer on switching from cigarettes or ST to ONPs. Over 4 weeks, participants randomized to use ONPs with high FBN and >99% S-nicotine (vs. other ONPs) will report higher prevalence of (H2a) partially switching to ONPs (use ONPs >14 days but continued usual product use) and (H2b) complete switching to ONPs by week 4. H2c: Associations of form and isomer with switching outcomes will be strongest in the high nicotine concentration arm.
Study Procedures:
Participants will complete three in-person visits. Visits involve randomized, double-blinded use of either small-particle ONPs or a distribution of particle-size ONPs (one assigned product per visit).
Visit 1
- 12-hour abstinence requirement prior to visit.
- Informed consent procedures.
- Baseline questionnaires.
- Exhaled carbon monoxide (CO) testing and pregnancy screening (if applicable).
- IV-line placement followed by four timed blood draws to assess plasma nicotine levels.
- 120-minute controlled ONP use session.
Post-use surveys assessing:
- Product appeal
- Withdrawal symptoms and relief
- Sensory scales
- Behavioral intentions
One-Week Switching Period (at-home)
Following Visit 1, participants enter a 7-day ad libitum use period using their assigned ONPs.
During this phase, participants complete online daily diary surveys (1 per day) to capture product use and switching behavior.
Visit 2
- 12-hour abstinence prior to visit.
- Exhaled CO testing and pregnancy screening (if applicable).
- IV-line placement and four timed blood draws (plasma nicotine levels).
- 120-minute controlled ONP use session.
- Post-use surveys (same as Visit 1).
One-Week Switching Period (at-home)
Following Visit 2, participants enter a 7-day ad libitum use period using their assigned ONPs.
During this phase, participants complete online daily diary surveys (1 per day) to capture product use and switching behavior.
Visit 3
- Completion of survey measures only (no product administration or IV-lines).
- Return of unused ONPs from the at-home switching period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small particle size oral nicotine pouches | Experimental | Procedure: Biospecimen Collection, Drug: Nicotine Oral Pouch, Other: Survey Administration, Other: Text Message-Based Navigation InterventionCLINIC VISIT: Participants sample a small particle size ONP product. Patients also undergo blood sample collection throughout study. SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior. |
| Variable particle size oral nicotine pouches | Experimental | Procedure: Biospecimen Collection, Drug: Nicotine Oral Pouch, Other: Survey Administration, Other: Text Message-Based Navigation InterventionCLINIC VISIT: Participants sample a variable particle size ONP product. Patients also undergo blood sample collection throughout study. SWITCHING PERIOD: Participants complete a 1-week ad libitum switching period using assigned ONPs. Daily diary surveys are completed remotely to track product use and switching behavior. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 21 or older
- Able to read and speak English
- Willing to abstain from tobacco, nicotine, and marijuana for at least 12 hours prior to study visits
- Exclusive use of ONPs (other product use <10x/mo).
- Exhaled CO reading <10 ppm
Key exclusion criteria (5 listed)
- Non-English speaker
- Individuals currently pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks associated with nicotine exposure and study procedures (e.g., blood draws).
- Individuals with unstable or significant psychiatric conditions are excluded to minimize risk and ensure reliable participation.
- Individuals actively attempting to quit nicotine use are excluded to avoid ethical concerns and ensure that study participation does not interfere with cessation efforts
- Non-nicotine users and regular tobacco users are excluded from the clinical trial component to ensure that participants have established use patterns appropriate for assessing ONP use behaviors.
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 CollectionUndergo blood sample collection | Procedure or surgery | Small particle size oral nicotine pouches, Variable particle size oral nicotine pouches |
| Nicotine Oral PouchInsert small particle size ONP | Drug | Small particle size oral nicotine pouches |
| Nicotine Oral PouchInsert variable particle size ONP | Drug | Variable particle size oral nicotine pouches |
| Survey AdministrationAncillary studies | Other | Small particle size oral nicotine pouches, Variable particle size oral nicotine pouches |
| Text Message-Based Navigation InterventionAlso: Automated Text Message-Based NavigationReceive text with a link to daily diary surveys | Other | Small particle size oral nicotine pouches, Variable particle size oral nicotine pouches |
Primary outcome
Nicotine Delivery, Cmax
Time frame: 2 weeks
Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.
7 secondary outcomes
Switching Behavior
Time frame: 2 weeks
Nicotine Delivery, Tmax
Time frame: 2 weeks
Nicotine Delivery, AUC
Time frame: 2 weeks
Craving Relief, QSU
Time frame: 2 weeks
Withdrawal, MNWS
Time frame: 2 weeks
Product Appeal, mCEQ
Time frame: 2 weeks
Intensity of Sensory Attributes, gLMS
Time frame: 2 weeks
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 17 Aug 2026.
- The JameslineLink provided by the sponsor.
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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 Phase 4 study testing Biospecimen Collection, Nicotine Oral Pouch and Survey Administration 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 10 inclusion and 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Nicotine Delivery, Cmax (time frame: 2 weeks). 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 17 Aug 2026.