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 cancer disparities 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.
Additional locations may be listed on ClinicalTrials.gov for NCT06763536.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Brittney Lee Keller-Hamilton
Phone: 614-366-9652
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 3 concentrations of oral nicotine pouches. Participants use the products ad libitum, starting with the lowest concentration, to determine their preferred concentration, over 2 weeks.
SWITCH PHASE: Participants receive their chosen oral nicotine pouches and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks.
Participants undergo carbon monoxide measurement throughout the study.
ARM II:
SAMPLING PHASE: Participants receive 2 different strengths of patches and 2 different strengths and 4 different flavors of 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 chosen nicotine patches and lozenges and use them in place of cigarettes and receive daily check-ins via smartphone application for 12 weeks.
Participants undergo carbon monoxide measurement throughout the study.
After completion of study treatment, patients are followed up every 4 weeks for 14 weeks.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorBrittney Lee Keller-Hamilton
