Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes

NCT ID: NCT04974489

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2021-08-03

Brief Summary

Tobacco use is the leading preventable cause of cancer and cancer deaths in the US. While most (69%) smokers want to quit, only 6% succeed in doing so each year. For many smokers, the addictiveness of nicotine makes quitting very difficult. To reduce cigarette smoking and resulting harms, FDA has announced a comprehensive approach to tobacco and nicotine regulation that includes moving toward a very low nicotine content (VLNC) standard for cigarettes. Greatly reduced nicotine levels would facilitate smoking cessation. However, the maximal success of the policy may require public understanding that, although these new cigarettes are less addictive, their high toxicity and carcinogenicity are unchanged. Yet, nearly half of adult smokers incorrectly think smoking VLNC cigarettes is less harmful than smoking current cigarettes (the VLNC misperception). Additionally, 24% of smokers said they would be less likely to quit if a VLNC regulation is enacted. Thus, the VLNC misperception may partially undermine a nicotine reduction policy. Although communication research suggests it is challenging to change people's incorrect understanding, new communication techniques may help reduce the VLNC misperception. In this randomized trial we will examine whether messages about the harm of VLNC cigarettes can reduce the VLNC misperception and increase intention to quit in a nicotine reduction scenario.

Detailed Description

In this study we will assess whether messages about the harm of VLNC cigarettes reduce the misperception that they are less harmful than regular cigarettes.

Recruitment:

We will enroll participants from an existing nationally representative panel.

Informed Consent:

Potential participants are part of an existing nationally representative panel and have already consented to participate in the panel. Before enrolling, participants will also be asked to consent to participate in this study via a consent form included in the study survey.

Randomization:

Survey software will randomly allocate participants to one of the four arms of the study (3 intervention arms or a control arm). Each study arm will have approximately the same number of participants.

Assessment:

Participants will complete a 15-minute survey. The survey will begin with an introduction to the concept of VLNC cigarettes. Then participants will be shown intervention or control messages, and their beliefs will be assessed.

Detailed Description of the Intervention:

Participants will be shown a set of 3 messages about the harms of VLNC cigarettes (intervention arms) or about littering (control arm). Each of the 3 intervention arms use a different theme to attempt to correct the VLNC misperception.

Conditions

Tobacco Use, Cigarette Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Emotion-based messages about the harm of VLNC

Group Type: EXPERIMENTAL

Emotion-based messages about the harm of VLNC

Intervention Type: BEHAVIORAL

Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.

Continued-harm-framed messages about the harm of VLNC

Group Type: EXPERIMENTAL

Continued-harm-framed messages about the harm of VLNC

Intervention Type: BEHAVIORAL

Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.

Myth-refuting messages about the harm of VLNC

Group Type: EXPERIMENTAL

Myth-refuting messages about the harm of VLNC

Intervention Type: BEHAVIORAL

Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Control messages about littering

Group Type: ACTIVE_COMPARATOR

Control messages about littering

Intervention Type: BEHAVIORAL

Participants in this arm will receive 3 control messages about littering during the survey data collection.

Interventions

Emotion-based messages about the harm of VLNC

Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.

Intervention Type: BEHAVIORAL

Continued-harm-framed messages about the harm of VLNC

Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.

Intervention Type: BEHAVIORAL

Myth-refuting messages about the harm of VLNC

Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Intervention Type: BEHAVIORAL

Control messages about littering

Participants in this arm will receive 3 control messages about littering during the survey data collection.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Current Cigarette Smoker
• Age 18 or older
• Enrolled in existing nationally representative panel where recruitment is based

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Justin Byron, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21CA234968

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-1284

Identifier Type: -

Identifier Source: org_study_id