NCT06763536

Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia

Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Oral nicotine pouches which contain nicotine but no tobacco leaf, present a new opportunity to reduce cancer risk among Appalachian adults who smoke. Oral nicotine pouches and nicotine replacement therapy may work well to reduce cigarette use for smokers in rural Appalachia.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate short-term changes in cigarette smoking patterns, including switching, abstinence from cigarettes, and frequency of smoking between oral nicotine patches (ONPs) and NRT. II. Compare product appeal, craving, withdrawal relief, and perceived cigarette dependence between ONPs and NRT. III. Examine sustained changes in tobacco use behaviors, including abstinence from cigarettes, purchase of ONPs/NRT, and continued use of ONPs/NRT. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: SAMPLING PHASE: Participants receive 2 concentrations of three different flavors of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks. SWITCH PHASE: Participants receive their preferred oral nicotine pouches and use them in place of cigarettes for 12 weeks. Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study. OBSERVATION PHASE: After completion of the intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends. ARM II: SAMPLING PHASE: Participants receive 2 different strengths of nicotine replacement therapy patches and 2 different strengths and 3 different flavors of nicotine replacement therapy lozenges. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration and flavor, over 2 weeks. SWITCH PHASE: Participants receive their preferred nicotine patches and lozenges and use them in place of cigarettes for 12 weeks. Participants complete surveys and have their carbon monoxide levels measured at various points throughout the study. OBSERVATION PHASE: After completion of intervention, participants complete a final follow-up survey, along with a carbon monoxide measure, 14 weeks after the intervention ends.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
OTHER	Carbon Monoxide Measurement	Undergo carbon monoxide measurement
OTHER	Nicotine Lozenge	Use nicotine lozenge
OTHER	Oral Nicotine Pouch	Use oral nicotine pouch
OTHER	Nicotine Patch	Use nicotine patch
OTHER	Survey Administration	measurements; data gathering
OTHER	Check-in Phone Calls	Check-in phone calls to study participants

Timeline

• Start date: 2025-06-13
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-01-08
• Last updated: 2025-06-22

Locations

1 site across 1 country: United States