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Clinical Trials/NCT06605924
NCT06605924CompletedNot Applicable

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

Johns Hopkins Bloomberg School of Public Health1 site in 1 country5,133 target enrollmentStarted: May 12, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
5,133
Locations
1
Primary Endpoint
Absolute perceived harm

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
13 Years to 120 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Control

No Intervention

Viewing a static advertisement - baseline language only

Tobacco-free

Experimental

Viewing a static advertisement

Intervention: Tobacco-free (Other)

Discrete

Experimental

Viewing a static advertisement

Intervention: Discrete (Other)

Convenient

Experimental

Viewing a static advertisement

Intervention: Convenient (Other)

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Secondary Outcomes

  • Perceived ability to satisfy nicotine cravings(Immediately after viewing ad)
  • Perceived ability to help one quit smoking(Immediately after viewing ad)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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