Clinical trial · Interventional
Appeal of Nicotine Pouches Versus Cigarettes in the Ohio Appalachia Population
Examining the Appeal of Nicotine Pouches in Ohio Appalachia
NCT05236894CI-TRIAL-00077343completedEarly 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 estimates the abuse liability of nicotine pouches with varying nicotine concentrations relative to cigarette smoking in Appalachian, Ohio and Ohio smokers. Nicotine pouches are a novel tobacco product with potential to reduce or increase the harm of tobacco use. Evaluating nicotine pouches abuse liability among smokers in Ohio including the unique demographic of Appalachia may clarify the public health effect of NPs in Appalachian Ohio and across Ohio. Results may inform public health efforts, policy, and clinical care aimed at reducing tobacco-related disparities.
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 |
|---|---|---|---|
| Cigarette Smoking-Related Carcinoma | Cigarette Smoking-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cigarette Smoking | Behavioral | — | UNRESOLVED |
| Nicotine Oral Pouch | Drug | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Aim 1: Arm I (lower dose nicotine pouch)
- description
- Patients receive lower dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
- interventionNames
- Drug: Nicotine Oral Pouch
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Aim 1: Arm II (higher dose nicotine pouches)
- description
- Patients receive higher dose nicotine pouch PO over 30 minutes at visits 1, 2, and 3.
- interventionNames
- Drug: Nicotine Oral Pouch
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Aim 1: Arm III (cigarette smoking)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Aim 1 Inclusion Criteria: * Age 21 years or older. * Reside in an Ohio Appalachian county. * 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. * Smoke at least 5 cigarettes per day for the past 30 days. Exclusion Criteria: * Use tobacco products other than cigarettes \>10 days per month. * Use NP in the past 3 months. * Unstable or significant psychiatric conditions (past and stable conditions will be allowed). * Pregnant, planning to become pregnant, or breastfeeding. * History of cardiac event or distress within the past 3 months. * Currently attempting to quit all tobacco use. * Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease. Aim 2 Inclusion Criteria: * Age 21 years or older. * Reside in a Ohio. * 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. * Smoke at least 5 cigarettes per day for the past 30 days. Exclusion Criteria: * Use tobacco products other than cigarettes \>10 days per month. * Use NP in the past 3 months. * Unstable or significant psychiatric conditions (past and stable conditions will be allowed). * Pregnant, planning to become pregnant, or breastfeeding. * History of cardiac event or distress within the past 3 months. * Currently attempting to quit all tobacco use. * Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease.
References
Publications (2)
- BACKGROUNDKeller-Hamilton B, Alalwan MA, Curran H, Hinton A, Long L, Chrzan K, Wagener TL, Atkinson L, Suraapaneni S, Mays D. Evaluating the effects of nicotine concentration on the appeal and nicotine delivery of oral nicotine pouches among rural and Appalachian adults who smoke cigarettes: A randomized cross-over study. Addiction. 2024 Mar;119(3):464-475. doi: 10.1111/add.16355. Epub 2023 Nov 14. PMID 37964431
- BACKGROUNDKeller-Hamilton B, Curran H, Alalwan M, Hinton A, Brinkman MC, El-Hellani A, Wagener TL, Chrzan K, Atkinson L, Suraapaneni S, Mays D. Evaluating the Role of Nicotine Stereoisomer on Nicotine Pouch Abuse Liability: A Randomized Crossover Trial. Nicotine Tob Res. 2025 Mar 24;27(4):658-665. doi: 10.1093/ntr/ntae079. PMID 38713545