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THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health

RecruitingPhase 4Ages 21 Years - anyAllOhio State University Comprehensive Cancer Center
NCT07503925 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Biospecimen Collection
  • Nicotine Oral Pouch
  • Nicotine Oral Pouch
  • Survey Administration
  • Text Message-Based Navigation Intervention
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Where

1 site
Ohio State University Comprehensive Cancer Center
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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