Examining the Impact of Nicotine Pouches in Rural Ohio and Ohio Appalachia

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial examines the impact of nicotine patches on preventing cancer in rural and Appalachia Ohio residents. Nicotine pouches are new smokeless tobacco products that are marketed as substitutes for smokeless tobacco and are gaining in popularity. There is little research on how nicotine pouches will be adopted by residents of Ohio Appalachia and rural Ohio. This study may help researchers better understand the appeal and potential impact of nicotine pouches on public health.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Treatments: Lobeline; Nicotine

Criteria

Inclusion Criteria:

• Age 21 years or older

• Reside in an Ohio Appalachian county or surrounding rural area

• 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

• Daily use of smokeless tobacco for the past 3 months

Exclusion Criteria:

• Use tobacco products other than smokeless tobacco > 10 days per month

• Unstable or significant psychiatric conditions for > 1 year (past and stable conditions will be allowed)

• Pregnant, planning to become pregnant, or breastfeeding

• History of cardiac event or distress, including but not limited to uncontrolled high blood pressure, chest pain, significant oral lesions, throat, mouth, or other oral cancer, and shortness of breath within the past 1 year

• Working with a cessation counselor, using cessation devices such as Chantix or Wellbutrin, or planning to quit within the next 3 months

• Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, throat, tongue, or other oral cancer, lung cancer, or chronic obstructive pulmonary disease