Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia
Ohio State University Comprehensive Cancer Center
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.
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 differen…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * Report currently using smoking…
Interventions
- OtherCarbon Monoxide Measurement
Undergo carbon monoxide measurement
- OtherNicotine Lozenge
Use nicotine lozenge
- OtherOral Nicotine Pouch
Use oral nicotine pouch
- OtherNicotine Patch
Use nicotine patch
- OtherSurvey Administration
measurements; data gathering
- OtherCheck-in Phone Calls
Check-in phone calls to study participants
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio