# Acute effects and substitution feasibility of an oral nicotine pouch in smokeless tobacco users

> **NIH NIH F31** · VIRGINIA COMMONWEALTH UNIVERSITY · 2021 · $46,036

## Abstract

Project Summary/Abstract
Smokeless tobacco (SLT) exposes users to a variety of carcinogenic toxicants, yet nearly 6 million people in
the US use SLT despite health risks. SLT contains and delivers nicotine, a psychostimulant, that causes
dependence and hinders cessation efforts despite the observation that 45% of SLT users report interest in SLT
reduction/cessation. A novel, orally administered nicotine pouch marketed as “tobacco-free” recently has
become available for purchase in the US. Though the nicotine contained in these pouches is tobacco-derived,
the absence of tobacco leaf suggests less exposure to tobacco toxicants when compared to SLT. Therefore,
these pouches may provide an innovative tobacco cessation/reduced harm option for SLT users. However,
there are no objective data (i.e., not industry-sponsored) regarding the effects of these orally administered
nicotine pouches. The current study has two aims. Aim 1 will use clinical laboratory assessments to determine
the acute effects of three different doses of a novel, orally administered nicotine pouch in SLT users using a
within subjects, Latin-square order design. Participants will come to the Center for the Study of Tobacco
Products to complete four sessions that include an own brand SLT positive control and three ON nicotine
pouch conditions (2, 4, and 8 mg). Outcomes include plasma nicotine concentration and multiple subjective
measures. Aim 2 will investigate the feasibility of the oral nicotine pouch as an SLT substitute. Using a within-
subject design, 50 SLT-using participants interested in reducing their SLT use will complete three, five-day
conditions during which they will use either their own brand SLT (as a positive control), the most effective
nicotine-delivering pouch from Aim 1, or the least effective pouch from Aim 1 (as a negative control). Product
use and subjective effects will be recorded multiple times/day. The primary hypotheses are that: 1) In Aim 1,
plasma nicotine concentration will increase as oral nicotine pouch dose increases, such that the 8 mg nicotine
pouch will approach own brand SLT and 2) In Aim 2, the most effective nicotine pouch will substitute
completely for own brand SLT and will be adopted exclusively for one week by the majority of participants.
Results will address factors influencing SLT initiation, use, dependence and cessation and may inform
clinicians and policymakers, as well as future research examining SLT cessation options. Furthermore, this
application describes a comprehensive training plan that will advance the applicant’s expertise in the areas of
clinical behavioral pharmacology, clinical epidemiology, drug policy, and psychopharmacology, and will also
provide the applicant with the opportunity to learn new techniques and methodologies used in the translation of
clinical lab research into clinical trials, as well as new experimental and statistical techniques used in clinical
trial research. The proposed training will be invaluable...

## Key facts

- **NIH application ID:** 10314202
- **Project number:** 1F31DA054780-01
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Alisha Nicole Eversole
- **Activity code:** F31 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $46,036
- **Award type:** 1
- **Project period:** 2021-07-25 → 2024-07-24

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10314202

## Citation

> US National Institutes of Health, RePORTER application 10314202, Acute effects and substitution feasibility of an oral nicotine pouch in smokeless tobacco users (1F31DA054780-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10314202. Licensed CC0.

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