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Completed

NCT Number: NCT04805515

Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior

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.

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Key information

Conditions

Nicotine Dependence, Cigarettes Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine Corrective Messages

Behavioral

Messages communicating misperceptions of nicotine's role in health harms as well as misperceptions about reduced nicotine content cigarettes and e-cigarettes.

Primary outcomes

  1. Nicotine Beliefs

    Time frame: Wave 4 (weeks 11-13)

    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 outcomes

  1. Intention to Use Nicotine/Tobacco Products

    Time frame: Wave 4 (weeks 11-13)

    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.

  2. Tobacco Use

    Time frame: Wave 4 (weeks 11-13)

    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).

Other outcomes

  1. Attitudes About Nicotine

    Time frame: Wave 4 (weeks 11-13)

    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).

  2. Nicotine Related Norms

    Time frame: Wave 4 (weeks 11-13)

    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.

  3. Behavioral Control

    Time frame: Wave 4 (weeks 11-13)

    One item assessing confidence to resist smoking cigarettes when others are smoking (1=not at all confident to 4=very confident).

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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