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

NCT ID: NCT07111234

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Cigarette Smoking-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
In a double-blind, randomized crossover design, N=30 adult daily cigarette smokers will sample 4 ONPs with varying flavor and synthetic coolant properties. Participants are blinded to their study product(s) and will not be unblinded.

Study Groups

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Chill (WS-3 only)

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.

Group Type EXPERIMENTAL

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Ancillary studies

Nicotine Oral Pouch

Intervention Type DRUG

Sample randomly-ordered ONPs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Menthol (menthol only)

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.

Group Type EXPERIMENTAL

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Ancillary studies

Nicotine Oral Pouch

Intervention Type DRUG

Sample randomly-ordered ONPs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Peppermint (menthol+WS-3)

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.

Group Type EXPERIMENTAL

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Ancillary studies

Nicotine Oral Pouch

Intervention Type DRUG

Sample randomly-ordered ONPs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Smooth (no menthol or WS-3)

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.

Group Type EXPERIMENTAL

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Ancillary studies

Nicotine Oral Pouch

Intervention Type DRUG

Sample randomly-ordered ONPs

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Usual brand cigarette visit

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.

Group Type EXPERIMENTAL

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Smoke usual brand cigarette

Intervention Type DRUG

Participant will smoke their usual brand of cigarette during 1 study visit for 5 minutes.

Interventions

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Carbon Monoxide Measurement

Ancillary studies

Intervention Type PROCEDURE

Nicotine Oral Pouch

Sample randomly-ordered ONPs

Intervention Type DRUG

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Smoke usual brand cigarette

Participant will smoke their usual brand of cigarette during 1 study visit for 5 minutes.

Intervention Type DRUG

Other Intervention Names

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Carbon Monoxide CMONOX ZYN

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Brittney Keller-Hamilton

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brittney L Keller-Hamilton, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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The Ohio State University Comprehensive Cancer Center

Role: CONTACT

Phone: 800-293-5066

Email: [email protected]

Facility Contacts

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Brittney L. Keller-Hamilton, PhD, MPH

Role: primary

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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NCI-2025-04693

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-24236

Identifier Type: -

Identifier Source: org_study_id