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

Behavior, Risk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192316
• Other study ID #: OSU-23115
• Secondary ID: NCI-2023-08947U5
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 14, 2028

Study information

• Verified date: April 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State University Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 14, 2028
• Est. primary completion date: September 14, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 and are one of the following:
• 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.

Related Conditions & MeSH terms

• Behavior, Risk

Intervention

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 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.

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ONP Trial (Lapse Task)	This is a valid behavioral measure that was originally developed for smoking cue reactivity research and used in prior work by others and our team. The lapse task will assess ONP trial, time to trial, and ONP product selection.	Single Time Point for 25 Minutes
Primary	Visual Attention - Dwell Time	Visual attention will be measured via eye movements using SmartEye AI-X eye tracker with a 60 Hz sampling rate. Areas of interest (AOIs) will be predefined for each pack image including: 1) Full pack image; 2) Nicotine concentration; 3) Nicotine source claim; 4) Branding (i.e., brand name, flavors); 5) Warning label. A primary outcome for visual attention will be dwell time on AOIs.	1 day (Single Time Point: During Exposure)
Primary	Visual Attention - Time to First Fixation	Visual attention will be measured via eye movements using SmartEye AI-X eye tracker with a 60 Hz sampling rate. Areas of interest (AOIs) will be predefined for each pack image including: 1) Full pack image; 2) Nicotine concentration; 3) Nicotine source claim; 4) Branding (i.e., brand name, flavors); 5) Warning label. A primary outcome for visual attention will be time to first fixation on AOIs.	1 day (Single Time Point: During Exposure)
Primary	Visual Attention - Number of Fixations	Visual attention will be measured via eye movements using SmartEye AI-X eye tracker with a 60 Hz sampling rate. Areas of interest (AOIs) will be predefined for each pack image including: 1) Full pack image; 2) Nicotine concentration; 3) Nicotine source claim; 4) Branding (i.e., brand name, flavors); 5) Warning label. A primary outcome for visual attention will be number of fixations (i.e., saccades) to AOIs.	1 day (Single Time Point: During Exposure)
Primary	Cognitive Attention	Conceptualized as the cognitive resources allocated to encode a message into working memory, attention will be operationalized as the difference in heart rate (HR) between a baseline period prior to each pack image and during each second of the pack image exposure assessed with ECG. Beats per minute (BPM) will be collected with the Shimmer3 sampled at 512 Hz. This is an established psychophysiological measure of cognitive resources devoted to stimuli processing.	1 day (Single Time Point: During Exposure)
Primary	Arousal	Arousal is an indicator of physiological activation of the sympathetic nervous system and will be measured by skin conductance using Shimmer3 Galvanic Skin Response EDA sensors sampled at 128 Hz	1 day (Single Time Point: During Exposure)
Primary	Recall	We will capture unaided recall, a measure of storage in memory, via 3 open ended questions on a questionnaire pertaining to nicotine concentration, brand names, and source information corresponding to conditions to which participants are randomized. Responses will be coded, and coding reliability will be established, to create a score with higher values reflecting better recall of information about nicotine dimensions in the stimuli.	1 day (Single Time Point: During Exposure)
Primary	ONP Perceptions	We will capture perceptions of ONPs with 7 items that align with expert recommendations for assessing cognitive and affective aspects of tobacco risk perceptions. Items will assess perceived risk of health harm from ONPs, perceived risk of addiction from ONPs, worry about harm, and worry about addiction. The items are on a 1-7 response scale, have excellent reliability, and are averaged to create an overall score.	1 day (Single Time Point: During Exposure)
Primary	ONP Perceptions Relative to Other Products	We will also capture perceived harm and addictiveness of ONPs relative to cigarettes, smokeless tobacco, and electronic cigarettes using valid items on a 1-5 response scale.	1 day (Single Time Point: During Exposure)
Primary	ONP Intentions	We will assess curiosity, interest, and likelihood of using ONPs post-exposure. These are valid predictors of future use of novel tobacco and nicotine products among never users. Items are on a 1-7 scale, have excellent reliability, and are combined to create an overall ONP intentions score.	1 day (Single Time Point: During Exposure)

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