Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior

NCT04805515 | Completed Results

• 2 other identifiers: 00001374R01DA051001
• Study Type: interventional
• Target: 794
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence, Cigarettes

Outcome Measures

Primary Outcomes (1)

• 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.

  Wave 4 (weeks 11-13)

Secondary Outcomes (2)

• Intention to Use Nicotine/Tobacco Products

  Wave 4 (weeks 11-13)

• Tobacco Use

  Wave 4 (weeks 11-13)

Other Outcomes (3)

• Attitudes About Nicotine

  Wave 4 (weeks 11-13)

• Nicotine Related Norms

  Wave 4 (weeks 11-13)

• Behavioral Control

  Wave 4 (weeks 11-13)

Study Arms (2)

Nicotine Corrective Messages

EXPERIMENTAL

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.

Behavioral: Nicotine Corrective Messages

Delayed Message Control

NO INTERVENTION

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.

Interventions

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.

Nicotine Corrective Messages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Vermont: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

• Villanti AC, Peasley-Miklus C, Mercincavage M, Mays D, Donny EC, Cappella JN, Strasser AA. Effect of nicotine corrective messaging on nicotine-related beliefs in US adults: a randomised controlled trial. Tob Control. 2025 Apr 1;34(2):162-168. doi: 10.1136/tc-2023-058252.

  PMID: 37989586 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Andrea Villanti
• Organization: Rutgers Center for Tobacco Studies

andrea.villanti@rutgers.edu

732 235 9585

Study Officials

• Andrea C Villanti, PhD, MPH

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: March 18, 2021
• Study Start: February 12, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of the study and publication of the primary findings, for a period up to 2 years.
• 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.

Locations

US (1)