Brittney Keller-Hamilton

Introduction: Oral nicotine pouch (ONP) sales are growing in the United States, yet little is known about how they are used (eg, use topography). To inform assessments of ONPs’ abuse liability, toxicity, and health effects, we examined typical ONP use behaviors and topographies among adults who use ONPs. Methods: We conducted 16 virtual focus groups (two to nine participants each) with 44 adults who reported using ONPs at least some days per week: 16 adults with no history of cigarette smoking or smokeless tobacco (SLT) use and 28 adults with a history of cigarette smoking or SLT use. Participants completed an online survey and semi-structured focus group interview. Quantitative data were summarized descriptively, and qualitative transcripts underwent thematic analysis with a comparative approach. Results: Participants were 33 (SD = 11) years old on average and had used ONPs for 1.7 (SD = 1.5) years on average, 18% were women, and 82% used ONPs daily. Topography behaviors varied, with participants describing differing preferences for upper versus lower lip placement, frequent ONP movement around the mouth versus static “parking,” use of multiple ONPs simultaneously, and consecutive ONP additions without removal, ie, “stacking.” Participants described strategies to titrate nicotine delivery through placement techniques, use duration, and stacking. Conclusions: ONP use patterns vary among established users. Future evaluations of abuse liability, toxicity, and health effects should consider effects across different use topographies. Implications: This study provides the first in-depth qualitative characterization of real-world oral nicotine pouch use topography, revealing behaviors like extended use durations, lip placement, moisture manipulation, and stacking that all diverge from standardized clinical protocols. These findings can inform the design of human laboratory studies and switching trials by guiding participant instructions that better reflect natural use. Regulatory assessments of nicotine exposure and product effects, including those conducted to support the Food and Drug Administration's (FDA's) evaluation of oral nicotine pouch products, should account for the range of use topographies identified here.

Background: With the highest cancer incidence and mortality rates in the country, rural Appalachia has experienced a decades-long health decline, due in part to high smoking rates. Cigarette smoking prevalence exceeds 30% in much of the region. Oral nicotine pouches (ONPs), which contain nicotine but no tobacco, present an unexplored opportunity to reduce cigarette smoking and cancer incidence. Objectives: We outline the protocol for the Appalachian Research to Impact Smoking’s Effects (ARISE) study, a randomized controlled trial to determine whether ONPs affect cigarette smoking patterns short- and long-term, and to evaluate their abuse liability versus nicotine replacement therapy (NRT) in a large sample of Appalachian smokers (clinicaltrials.gov: NCT06763536). Methods: Between 2025 and 2029, we will recruit 1,000 adult smokers living in rural Appalachian counties across 11 states. Participants will be identified via media outreach, mobile cancer screening, community events, and respondent-driven sampling, then randomized to ONP or NRT and complete four study phases: Baseline, Sampling, Switch, and Observation. In the Sampling phase, participants will receive varied flavors and nicotine strengths of their assigned product and select preferred options for use. During the Switch Phase, they will attempt to quit smoking and switch completely to their assigned product. The Observation phase will monitor tobacco use after discontinuation of study products. Study procedures will be conducted online and by mail, including surveys, expired carbon monoxide verification, and product delivery. The primary outcome is 7-day biochemically verified cigarette abstinence at the end of the Switch Phase. Secondary outcomes include switching rates, product appeal, craving, withdrawal, dependence, and purchases during the Observation phase. An intention-to-treat log-binomial regression model will estimate the effect of intervention assignment on cigarette abstinence. Conclusions: Results will inform whether and how ONPs should be regulated, approached clinically, and used in public health interventions to reduce the burdens of cigarette smoking in Appalachia.

Research has established that increasing policy support among adults can encourage behavior change; however, policy support, particularly regarding Tobacco 21 (T21), remains understudied among youth. This study examines whether exposure to T21 policy messages can increase support for the policy and reduce intentions to use tobacco among youth. We recruited an online convenience sample of U.S. youth aged 18-20 (final analytic N = 583; about half with a history of tobacco use) who completed the study via Prolific and were randomly assigned to either a T21 or a control message condition. T21 messages promoted policy support, while control messages were neutral and unrelated to health. Participants viewed three messages based on their assigned condition and completed pre- and post-exposure surveys assessing T21 support and tobacco use intentions. Two repeated-measures ANCOVAs were used to test the impact of message exposure on these outcomes. Participants exposed to T21 messages showed a greater mean pre-to-post increase in support for T21 than those who viewed control messages, F (1, 574) = 11.39, p < .001. Exposure to T21 messages also resulted in a greater mean pre-to-post reduction in intentions to use tobacco compared to control, F (1, 574) = 5.98, p = 0.015. Our findings underscore that T21 messaging can increase youth support for tobacco policies and reduce future tobacco use intentions. Integrating policy-focused messaging could strengthen youth engagement with tobacco prevention campaigns and enhance tobacco control efforts.

Objective: Examine trends in the prevalence of oral nicotine pouch (ONP) use among U.S. college students. Participants: During the Spring 2025 semester (January-early May), we enrolled 578 undergraduate and 888 graduate students from a large Midwestern University. Methods: Students completed an online survey assessing ONP use and their reasons for use/nonuse. Their history of using other substances and sociodemographic characteristics were also assessed. Results: For the undergraduate and graduate samples, ever use of ONPs was 15.4% and 11.4%, respectively; monthly use was 2.9% and 2.5%, respectively. Prevalence was elevated in particular subgroups, such as undergraduate students who were members of a fraternity (41.2% ever ONP use). For both samples, the most commonly cited reason for ONP use was "I like the buzz." Conclusions: ONPs have become popular on U.S. college campuses. This trend has implications for nicotine addiction and underscores the need for further research and attention from public health.

Background and aims: Oral nicotine pouches (ONPs) contain varying proportions of freebase nicotine (FBN), with higher FBN expected to increase nicotine delivery across the oral mucosa. Because ONPs contain fewer toxicants than moist snuff and may serve as a reduced harm alternative for smokeless tobacco, we compared how the FBN in ONPs affects both nicotine pharmacokinetics and craving relief relative to moist snuff.Design: Three‐visit (90‐minute sessions; ≥48‐hour washout), single‐blind, randomized crossover study. Participants were asked to complete all visits within 1 month.Setting: Clinical facility in Columbus, Ohio, USA.Participants: N = 62 moist snuff users (M_age = 41 years, 96.8% male, 91.9% white, 33.9% had tried ONPs before), recruited through social media advertisements and participants' word‐of‐mouth from rural and Appalachian Ohio.Intervention: Following ≥12 hours of nicotine abstinence, participants used either a (1) low FBN peppermint ONP (27.4% FBN; 5.1 mg nicotine/pouch; Rogue brand), (2) high FBN peppermint ONP (70.2% FBN; 5.0 mg nicotine/pouch; Zyn brand) or (3) 2 g of usual brand moist snuff for 30 minutes. Participants completed the three study visits in one of six randomized orders.Measurements: Plasma nicotine and self‐reported craving were assessed at t = baseline, 5, 15, 30, 60 and 90 minutes. Plasma nicotine and craving relief at t = 30 minutes were primary and secondary outcomes, respectively.Findings: At t = 30 minutes, mean [standard deviation (SD)] plasma nicotine concentrations were 7.1 (2.8) ng/mL for low FBN ONP, 14.8 (6.4) ng/mL for high FBN ONP and 12.3 (8.4) ng/mL for moist snuff (all comparison Ps ≤ 0.001). Craving was lower for moist snuff (mean = 0.8) than either ONP (means = 1.4), with the low FBN ONP providing statistically significantly less craving relief than moist snuff (P < 0.001).Conclusions: The proportion of freebase nicotine in oral nicotine pouches appears to statistically significantly influence their nicotine delivery, with higher freebase nicotine oral nicotine pouches delivering more nicotine than usual brand moist snuff. However, craving appears to be higher when using oral nicotine pouches than usual brand moist snuff.

Background Oral nicotine pouches (ONPs) have rapidly gained popularity in recent years. While ONPs likely expose users to fewer toxicants than cigarettes, they contain nicotine and may initiate, sustain or increase nicotine addiction and dependence. Monitoring the ONP marketplace is essential to inform timely regulatory action. Methods We used Nielsen ScanTrack data to analyse ONP sales and prices from 2021 to 2024. Joinpoint regression assessed sales and price trends, and ordinary least squares regression evaluated the association between ONP sales and product characteristics. Results Monthly ONP unit sales increased significantly, from 327 million in July 2021 to 1046 million in May 2024—more than tripling over this period (pConclusions Policy-makers may need to consider the role of major manufacturers, product flavours, and nicotine content in shaping the market. Continued surveillance is warranted to assess trends in use, particularly among youth and non-tobacco users.