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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06192316
Status
Recruiting

Conditions

  • Behavior, Risk

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 3x3 between-subjects experimental exposure — BEHAVIORAL
    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 randomized to. Within each condition, pack images will vary by 4 brands and 4 flavors per brand. While viewing the images, we will collect psychophysiological data including heart rate, galvanic skin response, and eye tracking.

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Feb 2026
Primary completion
Sep 14, 2028
Completion
Sep 14, 2028

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Nicotine Concentration: None Displayed; Nicotine Source Claim 1
    Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
  • Experimental: Nicotine Concentration: None Displayed; Nicotine Source Claim 2
    Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
  • Experimental: Nicotine Concentration: None Displayed; Nicotine Source Claim 3
    Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
  • Experimental: Nicotine Concentration: Low; Nicotine Source Claim 1
    Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
  • Experimental: Nicotine Concentration: Low; Nicotine Source Claim 2
    Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
  • Experimental: Nicotine Concentration: Low; Nicotine Source Claim 3
    Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
  • Experimental: Nicotine Concentration: High; Nicotine Source Claim 1
    Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
  • Experimental: Nicotine Concentration: High; Nicotine Source Claim 2
    Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
  • Experimental: Nicotine Concentration: High; Nicotine Source Claim 3
    Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Primary Outcome Measure

Visual Attention - Dwell Time [ Time Frame: 1 day (Single Time Point: During Exposure) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Darren Mays, MPH, PhD
614-366-2953
Darren Mays, MPH, PhD (PRINCIPAL_INVESTIGATOR)

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