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

The Ohio State University

Status: Enrolling

Conditions: Cigarette Smoking-Related Carcinoma

Treatments: Drug: Smoke usual brand cigarette; Procedure: Carbon Monoxide Measurement; Other: Questionnaire Administration; Drug: Nicotine Oral Pouch

Study type: Interventional

Funder types: Other

Identifiers

NCT07111234

NCI-2025-04693 (Registry Identifier)

OSU-24236

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 5 patient groups

Chill (WS-3 only)

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Oral Pouch

Other: Questionnaire Administration

Procedure: Carbon Monoxide Measurement

Menthol (menthol only)

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Oral Pouch

Other: Questionnaire Administration

Procedure: Carbon Monoxide Measurement

Peppermint (menthol+WS-3)

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Oral Pouch

Other: Questionnaire Administration

Procedure: Carbon Monoxide Measurement

Smooth (no menthol or WS-3)

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Oral Pouch

Other: Questionnaire Administration

Procedure: Carbon Monoxide Measurement

Usual brand cigarette visit

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Procedure: Carbon Monoxide Measurement

Drug: Smoke usual brand cigarette