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NCT06315881 · ClinicalTrials.gov registry record · Phase 2
Informing Oral Nicotine Pouch Regulations to Promote Public Health
A Phase 2 study of Tobacco-Related Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT06315881: Recruiting Phase 2 study of Tobacco-Related Carcinoma, sponsored by Ohio State University Comprehensive Cancer Center.
NCT06315881 is a Phase 2 study of Tobacco-Related Carcinoma that is actively recruiting participants, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 160 participants, below the 1,493-participant average among 10 other Tobacco-Related Carcinoma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06315881, a Phase 2 study of Tobacco-Related Carcinoma, is actively recruiting participants, sponsored by Ohio State University Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Data will be used to assess the effects of nicotine concentration, form and isomer on the addiction potential and appeal of oral nicotine pouches (ONPs) relative to cigarettes and smokeless tobacco (ST). Generalized mixed effects models will be used to assess differences between the four ONP conditions and the usual product.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Nicotine Oral Pouch
- DRUG Cigarette
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-01-13 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 2 |
What NCT06315881 shows while recruiting
NCT06315881 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 1,493-participant average among 10 other Tobacco-Related Carcinoma trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Tobacco-Related Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT06315881 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06315881 about?
NCT06315881 is a clinical study titled "Informing Oral Nicotine Pouch Regulations to Promote Public Health". 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 re...
What is the current status of trial NCT06315881?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2025-01-13. Estimated completion is 2028-08-31.
What conditions does trial NCT06315881 study?
This clinical trial studies the following conditions: Tobacco-Related Carcinoma.
What interventions are being tested in trial NCT06315881?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Nicotine Oral Pouch (DRUG), Cigarette (DRUG).
Who is sponsoring clinical trial NCT06315881?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06315881 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tobacco-Related Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06315881's enrollment target sits among peer trials
160 9th of 10 higher than 2 of 10 other Tobacco-Related Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco-Related Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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