Testing Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Smoking-Related Cancer Risk in Rural Appalachia

What this Trial Is About

Researchers are comparing oral nicotine pouches to nicotine replacement therapy, which includes patches and lozenges, to help reduce cigarette smoking among adults living in rural Appalachia. This study aims to address the high rates of lung and oral cancers in Appalachia caused by cigarette smoking. The trial will evaluate changes in smoking habits, product appeal, cravings, withdrawal symptoms, and long-term use of these nicotine products. Participants are randomly assigned to one of two groups. In the oral nicotine pouch group, participants first sample different flavors and strengths over 2 weeks to find their preferred option, then use that product instead of cigarettes for 12 weeks. The nicotine replacement therapy group follows a similar process with patches and lozenges. Both groups complete surveys and have their carbon monoxide levels measured throughout the study. After the 12-week treatment, there is a 14-week observation phase with follow-up surveys and carbon monoxide testing. During the study, participants will complete questionnaires, use handheld devices to measure carbon monoxide, and receive phone check-ins. Researchers will assess cigarette abstinence, smoking frequency, product use, cravings, withdrawal symptoms, and continued use or purchase of the nicotine products. Total participation covers the sampling, switching, and observation phases, lasting several months to understand both short-term and sustained changes in smoking behavior.

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