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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: t
View:

• Read and speak English

• 21 years or older

• Smoke ≥ 5 cigarettes per day for the past year

• Willing to use Oral Nicotine Pouches (ONP) or Nicotine Replacement Therapy (NRT)

• Live in a rural Appalachian County

• Have a smartphone and/or willing to use a smartphone for study purposes (smartphones may be provided to participants for study purposes only)

• Willing to blow air into a handheld study device

• If capable of becoming pregnant, verbal confirmation of not being pregnant based on urine pregnancy test results

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Contact Information
Primary
The Ohio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
800-293-5066
Time Frame
Start Date: 2025-06-13
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 1000
Treatments
Experimental: Arm I (oral nicotine pouch)
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.
Active_comparator: Arm II (nicotine replacement therapy)
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.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov