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NCT06315881
Informing Oral Nicotine Pouch Regulations to Promote Public Health
Phase 2 trial testing Biospecimen Collection in Tobacco-Related Carcinoma in 160 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 160 |
| Start date | 13 January 2025 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 August 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Biospecimen Collection — full drug profile →
- Cigarette — full drug profile →
- Nicotine Oral Pouch — full drug profile →
- Nicotine Oral Pouch — full drug profile →
- Nicotine Oral Pouch — full drug profile →
- Nicotine Oral Pouch — full drug profile →
- Smokeless Tobacco — full drug profile →
- Survey Administration
- Text Message-Based Navigation Intervention
Conditions studied
- Tobacco-Related Carcinoma — all drugs for Tobacco-Related Carcinoma →
Sponsor
Ohio State University Comprehensive Cancer Center
Who can join
21 and older, any sex, with Tobacco-Related Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06315881
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Tobacco-Related Carcinoma
Currently open trials in the same condition.
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Other Ohio State University Comprehensive Cancer Center trials
Trials by the same sponsor.
- NCT06816979 — Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell · NA · not yet recruiting
- NCT07529483 — Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cysts · Phase 2 · not yet recruiting
- NCT07455513 — A Novel Tobacco Cessation Resource for Smokers With a Diagnosed or Suspected Thoracic Cancer · NA · not yet recruiting
- NCT07217990 — Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer · Phase 1, PHASE2 · not yet recruiting
- NCT07503925 — THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health · Phase 4 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06315881 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center
- Last refreshed: 13 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06315881.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing