Oral Nicotine Pouch Marketing Features Influence on Perceptions

Aim 2 Study - Novel "Tobacco-Free" Oral Nicotine Pouches: The Impact of Product Features and Marketing Influences on Abuse Liability, Perceptions, and Use Behavior in Smokers and Non-Nicotine Users

This study tests the effects of three oral nicotine marketing features on product perceptions.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

5133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21205
        • 2213 McElderry St.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Live in the US
  • For youth age <21: Never used any nicotine pouch
  • For adults: Smoked greater than or equal to 100 cigarettes in during lifetime
  • For adults: Currently smoke some or all days
  • For adults: No regular use of oral nicotine pouches
  • For adults: No past 30-day pouch use

Exclusion Criteria:

  • Do not live in the US
  • For youth age <21: Ever used nicotine pouches
  • For youth age <21: Greater than or equal to 100 lifetime uses of any other nicotine or tobacco product
  • For adults: Smoked <100 cigarettes in life
  • For adults: Does not currently smoke some or all days
  • For adults: Regular use of oral nicotine pouches
  • For adults: Past 30-day pouch use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tobacco-free
Viewing a static advertisement
Ad contains baseline language + language that product is tobacco-free
Experimental: Discrete
Viewing a static advertisement
Ad contains baseline language + language that product is discrete
Experimental: Convenient
Viewing a static advertisement
Ad contains baseline language + language that product is convenient
No Intervention: Control
Viewing a static advertisement - baseline language only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute perceived harm
Time Frame: Immediately after viewing ad
How harmful participant perceives the product to be. Participants will answer a survey item, How harmful do you think this product is to your health; with response options ranging from 0-Not at all harmful to 4-Extremely harmful.
Immediately after viewing ad
Relative perceived harm
Time Frame: Immediately after viewing ad
How harmful participant perceives the product to be, relative to other tobacco products. Participants will answer a survey item, Compared to the following products [cigarettes; little cigars/cigarillos/filtered cigars; e-cigarettes; smokeless tobacco; heated tobacco; alcohol; cannabis], how harmful do you think the advertised product is? with response options ranging from 0-a lot less harmful to 4-a lot more harmful.
Immediately after viewing ad
Absolute perceived addictiveness
Time Frame: Immediately after viewing ad
How addictive participant perceives the product to be. Participants will answer a survey item, How addictive do you think this product is; with response options ranging from 0-not at all addictive to 4-extremely addictive.
Immediately after viewing ad
Relative perceived addictiveness
Time Frame: Immediately after viewing ad
How addictive participant perceives the product to be, relative to other tobacco products. Participants will answer a survey item; Compared to the following products [cigarettes; little cigars/cigarillos/filtered cigars; e-cigarettes; smokeless tobacco; heated tobacco products; alcohol; cannabis], how addictive do you think the advertised product is; with response options ranging from 0-a lot less addictive to 4-a lot more addictive.
Immediately after viewing ad
Product appeal
Time Frame: Immediately after viewing ad
How appealing participant perceives the product to be. Participants will answer a survey item to indicate how much they agree or disagree with the statement, I am curious about the product in the ad;, with response options from 0-strongly disagree to 4-strongly agree.
Immediately after viewing ad
Use intention
Time Frame: Immediately after viewing ad
Perceived likelihood of using the product. Participants will answer a survey item to indicate how much they agree or disagree with the statement, I am interested in using the product in the ad, with response options from 0-strongly disagree to 4-strongly agree.
Immediately after viewing ad

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived ability to satisfy nicotine cravings
Time Frame: Immediately after viewing ad
Perceived ability of the product to satisfy one's nicotine carvings. Participants will answer a survey item to indicate how much they agree or disagree with the statement; The product in the ad would satisfy nicotine cravings, with response options from 0-strongly disagree to 4-strongly agree.
Immediately after viewing ad
Perceived ability to help one quit smoking
Time Frame: Immediately after viewing ad
Perceived ability of the product to help one quit smoking cigarettes. Participants will answer a survey item to indicate how much they agree or disagree with the statement;The product in the ad would help with quitting smoking;, with response options from 0-strongly disagree to 4-strongly agree.
Immediately after viewing ad

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Meghan Moran, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Actual)

November 18, 2025

Study Completion (Actual)

November 18, 2025

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00029102
  • R01DA055962 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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