Clinical trial · Interventional
THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health
THRIVE Study: Informing Oral Nicotine Pouch Regulations to Promote Public Health
NCT07503925CI-TRIAL-00122423THRIVErecruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tobacco-Related Carcinoma | Tobacco-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Nicotine Oral Pouch | Drug | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Text Message-Based Navigation Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Small particle size oral nicotine pouches
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Drug: Nicotine Oral Pouch
- Other: Survey Administration
- Other: Text Message-Based Navigation Intervention
- type
- EXPERIMENTAL
- label
- Variable particle size oral nicotine pouches
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.