Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences

Not Applicable

Not yet recruiting

• Conditions: Cigarette Smoking-Related Carcinoma
• Interventions: Procedure: Carbon Monoxide Measurement; Drug: Nicotine Oral Pouch; Other: Questionnaire Administration; Drug: Smoke usual brand cigarette

• Registration Number: NCT07111234
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

This clinical trial studies how the flavors and synthetic coolant properties in oral nicotine pouches (ONPs) compare to one another and how these characteristics are perceived by users. ONPs are placed between the gum and lip, and the nicotine is absorbed in the mouth. They have a strong potential for harm reduction if smokers can switch to using them, and they are growing in popularity. One factor that could be contributing to the increase in popularity is the wide range of flavors, including mint or menthol. With recent flavor restriction policies that have gone into effect in certain areas of the United States, ONPs are now including synthetic cooling agents (WS-3) in place of the flavors. They provide a cooling sensation, but do not have a characterizing flavor, like mint or menthol, allowing them to be sold where flavor restriction policies are in place. Learning more about the flavors and cooling properties in ONPs and user preferences may help researchers guide future ONP regulation and understand how these characteristics may be used as a potential harm reduction or quit smoking tool.

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate the individual and joint effects of menthol flavors and WS-3 on appeal of ONPs.

II. Test the individual and joint effects of menthol flavors and WS-3 on self-reported relief of withdrawal and craving symptoms associated with use of ONPs.

II. Compare demand for ONPs that vary according to menthol flavors and WS-3.

OUTLINE: Participants are randomized to sample 4 ONPs in a 1 visit, 4-session, randomized cross-over study.

Participants sample four randomly-ordered ONPs with flavors consisting of WS-3 only, menthol only, menthol + WS-3, and no menthol or WS-3 over 10 minutes each, with washout periods of 10 minutes between each ONP use period.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2025-09-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 cigarettes
• Smokes >= 5 cigarettes/day for past year

Exclusion Criteria

• Use other tobacco products (including ONPs) more than 10 days per month
• Unstable or significant psychiatric conditions (past and stable conditions allowed)
• Pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each visit)
• History of cardiac event or distress within the past 3 months
• Currently attempting to quit all tobacco use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chill (WS-3 only)	Carbon Monoxide Measurement	Participants receive Chill-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Chill (WS-3 only)	Nicotine Oral Pouch	Participants receive Chill-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Chill (WS-3 only)	Questionnaire Administration	Participants receive Chill-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Menthol (menthol only)	Carbon Monoxide Measurement	Participants receive Menthol-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Menthol (menthol only)	Nicotine Oral Pouch	Participants receive Menthol-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Menthol (menthol only)	Questionnaire Administration	Participants receive Menthol-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Peppermint (menthol+WS-3)	Carbon Monoxide Measurement	Participants receive Peppermint-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Peppermint (menthol+WS-3)	Nicotine Oral Pouch	Participants receive Peppermint-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Peppermint (menthol+WS-3)	Questionnaire Administration	Participants receive Peppermint-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Smooth (no menthol or WS-3)	Carbon Monoxide Measurement	Participants receive Smooth-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Smooth (no menthol or WS-3)	Nicotine Oral Pouch	Participants receive Smooth-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Smooth (no menthol or WS-3)	Questionnaire Administration	Participants receive Smooth-flavored nicotine pouch over 10 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and an oral tobacco purchase task.
Usual brand cigarette visit	Carbon Monoxide Measurement	Participants smoke their usual brand cigarette over 5 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and a tobacco purchase task.
Usual brand cigarette visit	Questionnaire Administration	Participants smoke their usual brand cigarette over 5 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and a tobacco purchase task.
Usual brand cigarette visit	Smoke usual brand cigarette	Participants smoke their usual brand cigarette over 5 minutes and will complete questionnaires assessing measures of product appeal, sensory ratings and a tobacco purchase task.

Primary Outcome Measures

Name	Time	Method
Sensory ratings	5, 15, and 30 minutes after initial product use. To be completed on the day of the study visit. The visit will last approximately 2.5 hours	Sensory ratings will be evaluated with the general Labeled Magnitude Scale (gLMS), a 5-item self-report measure completed following ONP use. Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.
Withdrawal and Craving	0, 5, 15, and 30 minutes after initial product use.To be completed on the day of the study visit. The visit will last approximately 2.5 hours	Nicotine withdrawal and craving will be assessed using the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS is the sum of 8 items rated on a 5-point scale from 0 (none) to 4 (severe) with scores ranging from 0 to 32; MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate greater withdrawal/craving.
Appeal ratings	5, 15, and 30 minutes after initial product use. To be completed during the cigarette visit.	The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective appeal. The 11-item mCEQ includes five subscales: Satisfaction, Psychological Reward, Aversion, Enjoyment, and Craving Reduction. Individual items are rated from 1 (not at all) to 7 (extremely likely) and are averaged to create each subscale also ranging from 1 to 7. Higher values indicate greater levels of satisfaction, reward, aversion, enjoyment, and craving reduction.
Demand indices	At the end of each ONP sampling session. To be completed on the day of the study visit. The visit will last approximately 2.5 hours	After product use, participants will complete a purchase task to assess demand indices including demand elasticity.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States