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

The Ohio State University

Status: Enrolling

Conditions: Behavior, Risk

Treatments: Behavioral: 3x3 between-subjects experimental exposure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06192316

NCI-2023-08947 (Registry Identifier)

OSU-23115

U54CA287392 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 9 patient groups

Nicotine Concentration: None Displayed; Nicotine Source Claim 1

Experimental group

Description:

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

Treatment:

Behavioral: 3x3 between-subjects experimental exposure

Nicotine Concentration: None Displayed; Nicotine Source Claim 2

Experimental group

Description:

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

Treatment:

Behavioral: 3x3 between-subjects experimental exposure

Nicotine Concentration: None Displayed; Nicotine Source Claim 3

Experimental group

Description:

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

Treatment:

Behavioral: 3x3 between-subjects experimental exposure

Nicotine Concentration: Low; Nicotine Source Claim 1

Experimental group

Description:

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

Treatment:

Behavioral: 3x3 between-subjects experimental exposure

Nicotine Concentration: Low; Nicotine Source Claim 2

Experimental group

Description:

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

Treatment:

Behavioral: 3x3 between-subjects experimental exposure

Nicotine Concentration: Low; Nicotine Source Claim 3

Experimental group

Description:

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

Treatment:

Behavioral: 3x3 between-subjects experimental exposure

Nicotine Concentration: High; Nicotine Source Claim 1

Experimental group

Description:

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

Treatment:

Behavioral: 3x3 between-subjects experimental exposure

Nicotine Concentration: High; Nicotine Source Claim 2

Experimental group

Description:

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

Treatment:

Behavioral: 3x3 between-subjects experimental exposure

Nicotine Concentration: High; Nicotine Source Claim 3

Experimental group

Description:

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

Treatment:

Behavioral: 3x3 between-subjects experimental exposure