Clinical trial · Interventional
Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia
NCT05730439CI-TRIAL-00109474completedEarly Phase 1ClinicalTrials.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)
This clinical trial examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents. Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity. There is little research on how nicotine pouches will be adopted by residents of Ohio Appalachia and rural Ohio. This study may help researchers better understand the appeal and potential impact of nicotine pouches on public health.
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 |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Smokeless Tobacco | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Arm I (usual SLT, ZYN NP, Rogue NP)
- description
- Participants receive their usual brand of smokeless tobacco at study visit 1, ZYN brand nicotine patch at study visit 2, and Rogue brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
- interventionNames
- Procedure: Biospecimen Collection
- Drug: Nicotine Oral Pouch
- Other: Questionnaire Administration
- Drug: Smokeless Tobacco
- type
- EXPERIMENTAL
- label
- Arm II (usual SLT, Rogue NP, ZYN NP)
- description
- Participants receive their usual brand of smokeless tobacco at study visit 1, Rogue brand nicotine patch at study visit 2, and ZYN brand nicotine patch at study visit 3. Participants also undergo IV line insertion and collection of blood on study.
- interventionNames
- Procedure: Biospecimen Collection
- Drug: Nicotine Oral Pouch
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Age 21 years or older * Reside in an Ohio Appalachian county or surrounding rural area * Willing to complete study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits * Ability to read and speak English * Daily use of smokeless tobacco for the past 3 months Exclusion Criteria: * Use tobacco products other than smokeless tobacco \> 10 days per month * Unstable or significant psychiatric conditions for \> 1 year (past and stable conditions will be allowed) * Pregnant, planning to become pregnant, or breastfeeding * History of cardiac event or distress, including but not limited to uncontrolled high blood pressure, chest pain, significant oral lesions, throat, mouth, or other oral cancer, and shortness of breath within the past 1 year * Working with a cessation counselor, using cessation devices such as Chantix or Wellbutrin, or planning to quit within the next 3 months * Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, throat, tongue, or other oral cancer, lung cancer, or chronic obstructive pulmonary disease
References
Publications (0)
Data not yet available
No reference posted for this study.