Clinical trial NCT06192316: Human Laboratory Study of the Effects of Nicotine Product Claims on Appeal, Perceptions, and Use Behavior
Official title: Human Laboratory Study of the Effects of Nicotine Product Claims on Appeal, Perceptions, and Use Behavior
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavior, Risk
Keywords: oral nicotine pouch
cancer control
cancer prevention
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-01-05
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates knowledge, feelings and thoughts regarding nicotine products among young adults who are susceptible to but do not use tobacco/nicotine and adults who use tobacco/nicotine.

Detailed description: PRIMARY OBJECTIVES:

I. Examine the effects of nicotine concentration and source claims on engagement with ONP packaging using laboratory-based psychophysiological assessment.

II. Examine the effects of nicotine concentration and source claims on participant self-reported ONP perceptions, behavioral intentions, and ONP trial.

This is an experimental behavioral study. Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Eligibility criteria: Inclusion Criteria:

* Young adult susceptible non-users aged 18-24 who have never used ONPs and have never used but are susceptible to using either:

  * combustible tobacco only (cigarettes, cigars, waterpipe)
  * non-combustible tobacco only (ST, ECs, heated tobacco products)
  * or both combustible and non-combustible tobacco (i.e., dual susceptibility)
* Adult tobacco users aged 18-65 who have never used ONPs OR have used ONPs \>3 months ago and 10 times or less in their lifetime. All adult tobacco users must also be:

  * exclusive combustible tobacco users
  * exclusive non-combustible tobacco users
  * dual users

    * For adult tobacco users, we will define current use as use of combustible and/or non-combustible tobacco every day or some days for 6 months or longer
* Willing and able to complete an in-person lab visit.

Exclusion Criteria:

* Age \< 18 or \> 65
* Are not susceptible non-users or current tobacco users
* Are unwilling or unable to complete and in person lab visit.
* Have used ONPs within the past 3 months
* Have used ONPs more than 10 times in their lifetime

Primary outcomes:
measure: Visual Attention - Dwell Time
timeFrame: 1 day (Single Time Point: During Exposure)
measure: Visual Attention - Time to First Fixation
timeFrame: 1 day (Single Time Point: During Exposure)
measure: Visual Attention - Number of Fixations
timeFrame: 1 day (Single Time Point: During Exposure)
measure: Cognitive Attention
timeFrame: 1 day (Single Time Point: During Exposure)
measure: Arousal
timeFrame: 1 day (Single Time Point: During Exposure)
measure: Recall
timeFrame: 1 day (Single Time Point: During Exposure)
measure: ONP Perceptions
timeFrame: 1 day (Single Time Point: During Exposure)
measure: ONP Perceptions Relative to Other Products
timeFrame: 1 day (Single Time Point: During Exposure)
measure: ONP Intentions
timeFrame: 1 day (Single Time Point: During Exposure)
Secondary outcomes:
Other outcomes:
measure: ONP Trial (Lapse Task)
timeFrame: Single Time Point for 25 Minutes
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Darren Mays, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: