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Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Use Escalation Among Young Adult Electronic Nicotine Delivery Systems Users

Primary Purpose

Message Exposure (Sequence: Regular Then Flavor), Message Exposure (Sequence: Flavor Then Regular), No Message Exposure (Control Condition)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure to Anti-Vaping Messages (generic themes then flavor-specific themes)
Exposure to Anti-Vaping Messages (flavor-specific themes then generic themes)
Exposure to Anti-Vaping Messages (no message exposure)
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Message Exposure (Sequence: Regular Then Flavor) focused on measuring health message intervention, randomized controlled trial

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • used e-cigarettes or other vaping devices at least 3 days during the past 30 days
  • did not smoke a cigarette, even one or two puffs, during the past 30 days
  • Magnetic resonance imaging (MRI) compatible and safe

Exclusion Criteria:

  • used e-cigarettes or other vaping devices for less than 3 days during the past 30 days
  • any use of cigarettes during the past 30 days
  • history of a major neurological, psychiatric, or medical disorder
  • MRI contraindications

Sites / Locations

  • UGA Bio-imaging Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Message exposure (sequence: regular PSAs then flavor PSAs)

Message exposure (sequence: flavor PSAs then regular PSAs)

No message exposure (control condition)

Arm Description

Participants randomly assigned to this arm will receive weekly emails and text messages of regular PSAs (i.e., focused in general on the negative consequences of vaping) for the first 6 months of the study, and will then receive weekly emails and text messages of flavor PSAs (i.e., focused specifically on harms and negative consequences associated with vaping flavored e-cigarette products) for the second 6 months of the study.

Participants randomly assigned to this arm will receive weekly emails and text messages of flavor PSAs (i.e., focused specifically on harms and negative consequences associated with vaping flavored e-cigarette products) for the first 6 months of the study, and will then receive weekly emails and text messages of regular PSAs (i.e., focused in general on the negative consequences of vaping) for the second 6 months of the study.

Participants will not be receiving any PSA exposure over the 12 months.

Outcomes

Primary Outcome Measures

Self-report monthly smoking severity
The monthly number of cigarettes smoked will be assessed with the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily cigarette use for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly smoking severity measure. The greater the number, the higher the smoking severity in that month.
Self-report monthly vaping severity
The monthly number of vaping sessions (a vaping session refers to a minimum of about 15 puffs or vaping that lasts around 10 minutes) will be assessed with the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily vaping sessions for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly vaping severity measure. The greater the number, the higher the vaping severity in that month.
Exhaled carbon monoxide (CO) levels
Quarterly assessed exhaled CO levels quantified by parts per million (PPM)
Urine cotinine levels
Quarterly assessed urine cotinine levels (none, low, medium, high)

Secondary Outcome Measures

Self-report monthly other tobacco use severity
Frequency of other tobacco use will be assessed by the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily use of other tobacco for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly other tobacco use severity measure. The greater the number, the higher the other tobacco use severity in that month.
Cigarette smoking urge
Levels of cigarette smoking will be assessed with the Brief Questionnaire of Smoking Urges (10 items;1= strongly disagree, 7= strongly agree, with higher scores indicating greater smoking urge). Example item: "I have a desire for a cigarette right now".
Electronic cigarette dependence
Levels of nicotine dependence associated with vaping will be assessed with the Penn State Electronic Cigarette Dependence Index (which consists a total of 9 questions, some multiple-choice questions, and some Yes/No questions; Higher scores indicate greater e-cigarette dependence).
Message effectiveness perceptions
The perceived message effectiveness of the anti-vaping PSAs will be evaluated using the Perceived Message Effectiveness scale, which is consisted of four items (1 = strongly disagree, 5 = strongly agree). Example items included "This message was convincing" and "Reading this message helped me feel confident about how to best deal with vaping."
Vaping intention
Vaping intention will be assessed through three self-reported items (1=very unlikely, 5=very likely). Example item: "I plan to vape or use e-cigarettes, even one or two puffs, in the next 6 months".
Smoking intention
Smoking intention will be assessed through three self-reported items (1=very unlikely, 5=very likely). Example item: "I plan to smoke cigarettes, even one or two puffs, in the next 6 months".
Self-report monthly other substance use severity
The frequency of other substance use will be assessed by the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily use of other substances (including alcohol, marijuana, and other licit or illicit drug use) for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly other substance use severity measure. The greater the number, the higher the other substance use severity in that month.

Full Information

First Posted
May 1, 2022
Last Updated
August 16, 2023
Sponsor
University of Georgia
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1. Study Identification

Unique Protocol Identification Number
NCT05447325
Brief Title
Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Use Escalation Among Young Adult Electronic Nicotine Delivery Systems Users
Official Title
Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Use Escalation Among Young Adult Electronic Nicotine Delivery Systems Users
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
180 young adult vapers who are not current smokers will participate in a baseline functional magnetic resonance imaging (fMRI) experiment, prospectively linked to a 1-year randomized controlled trial. Baseline fMRI tasks will probe critical neurocognitive markers with high potential to account for individual differences in nicotine use prognosis and responsiveness to anti-vaping public service announcements (PSAs). Participants will be assigned randomly to a survey-only control condition, or one of two intervention orders, Regular PSA then Flavor PSA, and Flavor PSA then Regular PSA (n=60 each) in a 1-year counterbalanced crossover design. Every week intervention groups will receive anti-vaping PSAs either do not specifically address harms associated with vaping flavors (regular PSAs) or PSAs with a theme focusing on the harms of flavored vape products (flavor PSAs). Participants of the intervention groups will switch PSA exposure condition after 6 months. Their evaluations of the PSAs will be assessed with brief weekly online surveys. The links to the weekly online surveys will be sent via e-mail and text which allow them to access the surveys using any device with an internet browser. During the survey, the PSA of that week will first be displayed to PSA groups (n=120), followed by a query to provide message evaluation. Afterward, the survey questions will also assess their e-cigarette, cigarette, other tobacco use, and nicotine dependence, during the past week. The control group (n=60) will complete the surveys without viewing PSAs. In-person assessments at 3, 6, 9, and 12 months will biochemically confirm nicotine exposure.
Detailed Description
180 young adult current vapers will be recruited from multiple sources including the University of Georgia (UGA) student research pools from the Communication, Psychology, and Sociology Departments, posters, yard signs, local community liaisons, and via Craigslist and social media ads. The screening will begin with a brief online survey. The link to the survey will be included in the research pool websites, flyers, and social media ads. Those eligible after the screening will be invited to interview via Zoom for a more detailed assessment of eligibility. Eligible participants will be sent a pre-scan survey (about 0.5 hours) 24 hours prior to the in-person lab visit. They will then be invited to a 1.5-hour visit to UGA's Bioimaging Research Center (BIRC) and instructed to vape, or not, as usual that day. Upon arrival, participants' eligibility will be confirmed, and written informed consent will be obtained. Breath and urine samples will be collected to biochemically confirm the level of nicotine exposure (i.e., tobacco use severity), followed by the remaining pre-scan measures. Participants will then be trained to perform the fMRI tasks. During fMRI, they will wear earplugs and MR-compatible vision correction, if needed, and lie on the scanner table. Stimuli will be back-projected, and responses collected using a four-button response box configured to allow on-screen Likert scale ratings of 1-7, both via Eprime 3.0 software. MRI will last approximately 60min, followed by post-scan measures (about 0.5 hours). After the baseline fMRI scan, investigators will deliver static, visual, and textual anti-vaping public service announcements (PSAs) and assess participants' evaluations of the PSAs weekly through brief online surveys via e-mails and text messages. In the two PSA conditions, every week participants will receive an email and a text message through which a static visual anti-vaping PSA will be displayed to them before a query to evaluate the perceived effectiveness of the PSAs, followed by questions about their tobacco use status during the past week. Half of the PSA condition participants (n=60) will be exposed to regular PSAs that focus generally on the negative consequences of vaping, and the other half (n=60) will be exposed to flavor PSAs, which focus specifically on the harms and negative consequences associated with vaping flavored e-cigarettes. Flavor PSAs will be both drawn from existing regular PSAs and created by adding a flavor theme on regular PSAs because existing flavor PSAs are still rare. PSA condition participants will switch types of PSA exposure after 6 months. Each week a different PSA will be displayed to the participants. Therefore, half of the PSA condition participants will be exposed to 24 regular PSAs during the first 6 months, and then to 24 flavor PSAs during the second 6 months. For the other half of the PSA condition participants, they will also be displayed the same 48 PSAs, but in the reverse sequence, i.e., 24 flavor PSAs first, then 24 regular PSAs next. Participants in the control condition (n=60) will directly answer the survey questions about their tobacco use status during the past week without PSA exposure and evaluation. At 3-, 6-, 9- and 12-months participants will complete a 15-min visit that includes a CO confirmation for smoking, a urinary cotinine test for nicotine use, and other in-person follow-up measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Message Exposure (Sequence: Regular Then Flavor), Message Exposure (Sequence: Flavor Then Regular), No Message Exposure (Control Condition)
Keywords
health message intervention, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
In the PSA exposure conditions, half of the participants will receive regular PSA exposure during the first 6 months and then switch to receiving flavor PSA exposure during the second 6 months; the other half will first receive flavor PSAs, and then the regular PSAs.
Masking
Participant
Masking Description
The participants will be prevented from having knowledge of the interventions assigned to them.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Message exposure (sequence: regular PSAs then flavor PSAs)
Arm Type
Experimental
Arm Description
Participants randomly assigned to this arm will receive weekly emails and text messages of regular PSAs (i.e., focused in general on the negative consequences of vaping) for the first 6 months of the study, and will then receive weekly emails and text messages of flavor PSAs (i.e., focused specifically on harms and negative consequences associated with vaping flavored e-cigarette products) for the second 6 months of the study.
Arm Title
Message exposure (sequence: flavor PSAs then regular PSAs)
Arm Type
Experimental
Arm Description
Participants randomly assigned to this arm will receive weekly emails and text messages of flavor PSAs (i.e., focused specifically on harms and negative consequences associated with vaping flavored e-cigarette products) for the first 6 months of the study, and will then receive weekly emails and text messages of regular PSAs (i.e., focused in general on the negative consequences of vaping) for the second 6 months of the study.
Arm Title
No message exposure (control condition)
Arm Type
Experimental
Arm Description
Participants will not be receiving any PSA exposure over the 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Exposure to Anti-Vaping Messages (generic themes then flavor-specific themes)
Intervention Description
Messages are in the format of public service announcement (PSA) images that contain both textual (1-2 brief sentences) and illustrative visual components. The messages are designed to educate the participants about the harms and costs associated with e-cigarette use (e.g., negative health consequences, undesirable social perceptions, etc.). Half of the messages focus specifically on the harms and costs associated with using flavored vape products, while the other half address vaping harms broadly (i.e., not specifically focus on those related to flavored vaping). Participants in this arm will receive anti-vaping messages through emails and text messages every week. Specifically, over the course of a year, during the first six months, they will receive generic/regular PSAs that address vaping harms more broadly; during the second six months, they will receive flavor-specific PSAs that address vaping harms specifically associated with the use of flavored vape products.
Intervention Type
Behavioral
Intervention Name(s)
Exposure to Anti-Vaping Messages (flavor-specific themes then generic themes)
Intervention Description
Messages are in the format of public service announcement (PSA) images that contain both textual (1-2 brief sentences) and illustrative visual components. The messages are designed to educate the participants about the harms and costs associated with e-cigarette use (e.g., negative health consequences, undesirable social perceptions, etc.). Half of the messages focus specifically on the harms and costs associated with using flavored vape products, while the other half address vaping harms broadly (i.e., not specifically focus on those related to flavored vaping). Participants in this arm will receive anti-vaping messages through emails and text messages every week. Specifically, over the course of a year, during the first six months, they will receive flavor-specific PSAs that address vaping harms specifically associated with the use of flavored vape products; during the second six months, they will receive generic/regular PSAs that address vaping harms more broadly.
Intervention Type
Behavioral
Intervention Name(s)
Exposure to Anti-Vaping Messages (no message exposure)
Intervention Description
Participants will not receive any message intervention in this arm.
Primary Outcome Measure Information:
Title
Self-report monthly smoking severity
Description
The monthly number of cigarettes smoked will be assessed with the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily cigarette use for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly smoking severity measure. The greater the number, the higher the smoking severity in that month.
Time Frame
12 months
Title
Self-report monthly vaping severity
Description
The monthly number of vaping sessions (a vaping session refers to a minimum of about 15 puffs or vaping that lasts around 10 minutes) will be assessed with the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily vaping sessions for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly vaping severity measure. The greater the number, the higher the vaping severity in that month.
Time Frame
12 months
Title
Exhaled carbon monoxide (CO) levels
Description
Quarterly assessed exhaled CO levels quantified by parts per million (PPM)
Time Frame
12 months
Title
Urine cotinine levels
Description
Quarterly assessed urine cotinine levels (none, low, medium, high)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Self-report monthly other tobacco use severity
Description
Frequency of other tobacco use will be assessed by the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily use of other tobacco for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly other tobacco use severity measure. The greater the number, the higher the other tobacco use severity in that month.
Time Frame
12 months
Title
Cigarette smoking urge
Description
Levels of cigarette smoking will be assessed with the Brief Questionnaire of Smoking Urges (10 items;1= strongly disagree, 7= strongly agree, with higher scores indicating greater smoking urge). Example item: "I have a desire for a cigarette right now".
Time Frame
12 months
Title
Electronic cigarette dependence
Description
Levels of nicotine dependence associated with vaping will be assessed with the Penn State Electronic Cigarette Dependence Index (which consists a total of 9 questions, some multiple-choice questions, and some Yes/No questions; Higher scores indicate greater e-cigarette dependence).
Time Frame
12 months
Title
Message effectiveness perceptions
Description
The perceived message effectiveness of the anti-vaping PSAs will be evaluated using the Perceived Message Effectiveness scale, which is consisted of four items (1 = strongly disagree, 5 = strongly agree). Example items included "This message was convincing" and "Reading this message helped me feel confident about how to best deal with vaping."
Time Frame
12 months
Title
Vaping intention
Description
Vaping intention will be assessed through three self-reported items (1=very unlikely, 5=very likely). Example item: "I plan to vape or use e-cigarettes, even one or two puffs, in the next 6 months".
Time Frame
12 months
Title
Smoking intention
Description
Smoking intention will be assessed through three self-reported items (1=very unlikely, 5=very likely). Example item: "I plan to smoke cigarettes, even one or two puffs, in the next 6 months".
Time Frame
12 months
Title
Self-report monthly other substance use severity
Description
The frequency of other substance use will be assessed by the timeline follow-back measures. Specifically, participants will be asked to retrospectively estimate their daily use of other substances (including alcohol, marijuana, and other licit or illicit drug use) for the 7 days prior to the weekly survey date. The four weekly estimates will be averaged to create the monthly other substance use severity measure. The greater the number, the higher the other substance use severity in that month.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: used e-cigarettes or other vaping devices at least 3 days during the past 30 days did not smoke a cigarette, even one or two puffs, during the past 30 days Magnetic resonance imaging (MRI) compatible and safe Exclusion Criteria: used e-cigarettes or other vaping devices for less than 3 days during the past 30 days any use of cigarettes during the past 30 days history of a major neurological, psychiatric, or medical disorder MRI contraindications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiaying Liu, PhD
Phone
949-241-0652
Email
jiaying.liu@uga.edu
Facility Information:
Facility Name
UGA Bio-imaging Research Center
City
Athens
State/Province
Georgia
ZIP/Postal Code
30602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Mason
Email
kmason@uga.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The proposed research is under the 500k threshold for required resource sharing. The PI and research team are committed to resource sharing; however, in the context of the proposed study, no plans are in place to make data available outside of the research team.

Learn more about this trial

Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Use Escalation Among Young Adult Electronic Nicotine Delivery Systems Users

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