Actively Recruiting
Examining the Role of Cooling Agents in Oral Nicotine Pouches to Understand User Preferences and Appeal
Led by Ohio State University Comprehensive Cancer Center · Updated on 2025-12-24
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying flavors and synthetic cooling agents in oral nicotine pouches (ONPs) to understand how users perceive these products and their appeal. The trial aims to learn how menthol flavors and a synthetic cooling agent called WS-3 affect the appeal, relief of withdrawal and craving symptoms, and demand for ONPs. This information may help guide future regulation and explore ONPs as a potential tool to reduce harm from smoking. The study is sponsored by Ohio State University Comprehensive Cancer Center and focuses on cigarette smoking-related carcinoma risks. Participants will take part in a randomized, double-blind, crossover study where they sample four types of ONPs in one visit. The ONPs include Chill flavor (WS-3 only), Menthol flavor (menthol only), Peppermint flavor (menthol plus WS-3), and Smooth flavor (no menthol or WS-3). Each pouch is sampled for 10 minutes, with 10-minute breaks between each. Participants also smoke their usual brand cigarette for 5 minutes during the visit to compare experiences. Questionnaires and purchase tasks are completed after each sampling. During the approximately 2.5-hour study visit, participants complete assessments including appeal ratings, sensory ratings, withdrawal and craving questionnaires at multiple time points after product use, and demand indices after each ONP session. Researchers also measure carbon monoxide levels as part of ancillary studies. Participants must abstain from tobacco, nicotine, and marijuana for 12 hours before the visit. The study tracks user preferences and responses to different ONP flavors and cooling agents in a controlled setting.
CONDITIONS
Brief Title
Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older
- 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
- Has smoked 100 or more cigarettes
- Smokes at least 5 cigarettes per day for the past year
You will not qualify if you...
- Use of other tobacco products, including oral nicotine pouches, more than 10 days per month
- Unstable or significant psychiatric conditions (past stable conditions allowed)
- Pregnant, planning to become pregnant, or breastfeeding (verified by urine pregnancy test before each visit)
- History of cardiac event or distress within the past 3 months
- Currently attempting to quit all tobacco use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 day
Participants sample four different flavored oral nicotine pouches and smoke their usual brand cigarette during a single study visit, completing questionnaires assessing product appeal, sensory ratings, withdrawal and craving, and demand indices.
1 visit lasting about 2.5 hours (in-person)
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
5
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