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Recruiting NCT06192316

Human Laboratory Study of the Effects of Nicotine Product Claims on Appeal, Perceptions, and Use Behavior

No phase Interventional Behavior, Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3x3 between-subjects experimental exposure.
Who it may be relevant to
Registry conditions: Behavior, Risk. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Behavioral 3x3 between-subjects experimental exposure
    Participants will be randomly assigned to conditions in a 3 (Nicotine Concentration: None on label, Low, High) x 3 (Nicotine Source Claim: None, "Tobacco Free," "Synthetic Nicotine") between-subjects design. We will stratify randomization by young adult susceptible non-users and adult tobacco users for balance across the conditions. Participants will view 16 oral nicotine pouch pack images in random order that correspond to the nicotine concentration and source claim condition they are randomize

Primary outcome measures

  • Visual Attention - Dwell Time [Time frame: 1 day (Single Time Point: During Exposure)]
  • Visual Attention - Time to First Fixation [Time frame: 1 day (Single Time Point: During Exposure)]
  • Visual Attention - Number of Fixations [Time frame: 1 day (Single Time Point: During Exposure)]
  • Cognitive Attention [Time frame: 1 day (Single Time Point: During Exposure)]
  • Arousal [Time frame: 1 day (Single Time Point: During Exposure)]
  • Recall [Time frame: 1 day (Single Time Point: During Exposure)]
  • ONP Perceptions [Time frame: 1 day (Single Time Point: During Exposure)]
  • ONP Perceptions Relative to Other Products [Time frame: 1 day (Single Time Point: During Exposure)]
  • ONP Intentions [Time frame: 1 day (Single Time Point: During Exposure)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT06192316 · OSU-23115 · NCI-2023-08947 · U54CA287392

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗