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Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior

Primary Purpose

Nicotine Dependence, Cigarettes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine Corrective Messages
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nicotine Dependence, Cigarettes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • US resident age 18+
  • Member of the partnering consumer research panel conducting the survey
  • Non-smokers and tobacco cigarette smokers

Exclusion Criteria:

  • Age less than 18
  • Not a member of the partnering consumer research panel conducting the study

Sites / Locations

  • University of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nicotine Corrective Messages

Delayed Message Control

Arm Description

Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.

Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.

Outcomes

Primary Outcome Measures

Nicotine Beliefs
3 items assessing nicotine false beliefs (range 3-11), 6 items assessing nicotine replacement therapy (NRT) false beliefs (range 4-20), 4 items assessing e-cigarette false beliefs (range 2-14), 11 items assessing reduced nicotine content (RNC) cigarette false beliefs (range 14-45), and two items assessing beliefs about additive-free and organic tobacco products. Higher scale scores indicate a higher number of false beliefs.

Secondary Outcome Measures

Intention to Use Nicotine/Tobacco Products
Four items assessing intention to use tobacco cigarettes, e-cigarettes, NRT, and RNC cigarettes during the next 12 months. Adapted from PhenX Toolkit- Susceptibility to Tobacco Products, response options Definitely Yes; Probably Yes; Probably Not; Definitely Not. Outcomes reported for participants reporting Definitely Yes or Probably Yes to each item.
Tobacco Use
Number of days used tobacco in the past 30 days. Days used summed across eight different nicotine/tobacco products (e.g., tobacco cigarettes, e-cigarettes, cigars, NRT, RNC cigarettes).

Full Information

First Posted
February 11, 2021
Last Updated
November 15, 2022
Sponsor
University of Vermont
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04805515
Brief Title
Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior
Official Title
Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 2-arm, randomized controlled, population based trial to test the impact of multiple exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and non-smokers followed in waves over 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the same time points include intention to use nicotine/tobacco products and nicotine/tobacco use.
Detailed Description
This is a 2-arm, randomized controlled, population based trial to test the impact of multiple exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and non-smokers followed for 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the same time points include intention to use nicotine/tobacco products and nicotine/tobacco use. All participants will be recruited from a US national consumer research panel. Eligible participants will be U.S. adults ages 18+ who are enrolled members of the partnering consumer research panel. The sample will include non-smokers and smokers, oversampling current smokers (defined as smoking 100+ lifetime cigarettes and now smoking all or some days) to ensure the proportion of smokers in the sample reflects the ~15 % population smoking prevalence among adults. Panel members will be contacted by email with a brief study description and link to an eligibility screener and online informed consent form. Eligible and interested participants will complete the baseline (Wave 1) survey measures of nicotine beliefs and intentions/use of nicotine and tobacco products, after which they will be randomly assigned in equal numbers to the nicotine corrective message (NCM) intervention condition or the delayed message control condition. After completing the baseline survey, participants in the NCM condition will receive their first exposure to the corrective messages. In the Wave 2 survey, all participants will complete measures of nicotine beliefs and intentions/use of nicotine and tobacco products. Participants in the NCM condition will then receive their second exposure to study messages. Only participants in the NCM condition will receive the Wave 3 survey, which involves the third exposure to study messages. The Wave 4 survey will include the fourth exposure to study messages for those in the NCM condition and the final assessment of nicotine beliefs and intentions/use of nicotine and tobacco products for all participants. Upon completion of the final assessment, participants in the control condition will be exposed to the nicotine corrective messages and all participants will be directed to resources on quitting smoking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Cigarettes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention consists of 8 brief nicotine corrective public education messages delivered online. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
794 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotine Corrective Messages
Arm Type
Experimental
Arm Description
Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.
Arm Title
Delayed Message Control
Arm Type
No Intervention
Arm Description
Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.
Intervention Type
Behavioral
Intervention Name(s)
Nicotine Corrective Messages
Intervention Description
Messages communicating misperceptions of nicotine's role in health harms as well as misperceptions about reduced nicotine content cigarettes and e-cigarettes.
Primary Outcome Measure Information:
Title
Nicotine Beliefs
Description
3 items assessing nicotine false beliefs (range 3-11), 6 items assessing nicotine replacement therapy (NRT) false beliefs (range 4-20), 4 items assessing e-cigarette false beliefs (range 2-14), 11 items assessing reduced nicotine content (RNC) cigarette false beliefs (range 14-45), and two items assessing beliefs about additive-free and organic tobacco products. Higher scale scores indicate a higher number of false beliefs.
Time Frame
Wave 4 (weeks 11-13)
Secondary Outcome Measure Information:
Title
Intention to Use Nicotine/Tobacco Products
Description
Four items assessing intention to use tobacco cigarettes, e-cigarettes, NRT, and RNC cigarettes during the next 12 months. Adapted from PhenX Toolkit- Susceptibility to Tobacco Products, response options Definitely Yes; Probably Yes; Probably Not; Definitely Not. Outcomes reported for participants reporting Definitely Yes or Probably Yes to each item.
Time Frame
Wave 4 (weeks 11-13)
Title
Tobacco Use
Description
Number of days used tobacco in the past 30 days. Days used summed across eight different nicotine/tobacco products (e.g., tobacco cigarettes, e-cigarettes, cigars, NRT, RNC cigarettes).
Time Frame
Wave 4 (weeks 11-13)
Other Pre-specified Outcome Measures:
Title
Attitudes About Nicotine
Description
Three items on nicotine-related attitudes using semantic differentials across five-point Likert scales. 'Using Nicotine is:' Safe (1) - Dangerous (5); Positive (1) - Negative (5); Good (1) - Bad (5).
Time Frame
Wave 4 (weeks 11-13)
Title
Nicotine Related Norms
Description
Two items: "How would you describe most people's opinion of using nicotine?" and "Thinking about the people who are important to you, how would you describe their opinion on using nicotine?" with five-point Likert scale responses ranging from "very negative" (1) to "very positive" (5). Higher scores indicate positive norms of using nicotine.
Time Frame
Wave 4 (weeks 11-13)
Title
Behavioral Control
Description
One item assessing confidence to resist smoking cigarettes when others are smoking (1=not at all confident to 4=very confident).
Time Frame
Wave 4 (weeks 11-13)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: US resident age 18+ Member of the partnering consumer research panel conducting the survey Non-smokers and tobacco cigarette smokers Exclusion Criteria: Age less than 18 Not a member of the partnering consumer research panel conducting the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea C Villanti, PhD, MPH
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data from study surveys will be made available upon request and according to access criteria after completion of the study and publication of primary findings.
IPD Sharing Time Frame
After completion of the study and publication of the primary findings, for a period up to 2 years.
IPD Sharing Access Criteria
A data sharing agreement will be required for release of any data. Individuals requesting a copy of study data will need to submit a detailed research plan that includes the purpose of the proposed research, the variables required, the duration of the analysis phase, IRB approval with FWA information, investigator training in human subjects and other approvals specific to the individual datasets. They will also be required to submit a Data Protection Plan or Institutional Privacy Policy, describing the computing environment in which data will be managed and analyzed and how physical access to computing equipment will be controlled. Data will only be released once all IRB approvals and Human Subjects concerns have been addressed. The PI (A. Villanti) will be required to participate as an investigator on any project requiring data sharing.

Learn more about this trial

Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior

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