NCT05129592

Brief Summary

This study seeks to assess the efficacy of educational messages to correct misperceptions. A large proportion of the American population incorrectly believes that nicotine is the chemical responsible for causing cancer in tobacco products.1-3 This misconception may reduce the likelihood that established smokers who are unwilling or unable to quit tobacco product use completely will switch to less harmful non-combustible products. An online experiment will be used to test if corrective messages can reduce this misperception. The experiment will also test the effects of messages on beliefs about the relative harms of other tobacco products discussed in the message and accuracy of inferential beliefs. This will be accomplished by asking participants questions about two tobacco products that are not explicitly discussed in the messages. The experiment will test if the two components of "narrative coherence," a concept identified in previous reviews of misperception correction as effective,4-6 is effective at reducing misperceptions about nicotine. Component 1 provides an explanation for why the new information is correct and component 2 provides an explanation for how the false information came to be believed. This study will use a factorial design to test the efficacy of the component of coherence individually as well as together. Hypotheses and Research Questions: RQ1: Will participants exposed to different corrective message conditions differ in increased accuracy of beliefs (a) that nicotine does not cause cancer, (b) regarding the relative risk of e-cigarettes compared to cigarettes, (c) regarding the relative risk of very low nicotine cigarettes (VLNC) compared to cigarettes and (d) regarding the relative risk of nicotine replacement therapy compared to cigarettes. H1: Participants exposed to the nicotine corrective message with both components of coherence will be significantly more likely to increase accuracy of beliefs regarding the relative harms of (a) smokeless tobacco compared to cigarettes and (b) cigarillos relative to cigarettes compared to those exposed to messages with just one component or no components of coherence. H2: Participants exposed to the nicotine corrective message with both components of coherence will be significantly more likely to increase their intention to switch completely to a noncombustible product compared to those exposed to messages with just one component or no components of coherence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 22, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

October 1, 2021

Results QC Date

August 18, 2022

Last Update Submit

March 8, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Change in Accuracy of Belief That Nicotine Causes Cancer

    The extent to which participants agree or disagree with the following statement: The substance nicotine causes cancer. Response options are a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."

    Baseline and up to 5 minutes after receiving the corrective message

  • Change in Relative Harm Beliefs Regarding E-cigarettes

    "The next questions are about electronic cigarettes. You may also know them as e-cigarettes, vapes, vape pens, mods, or by brand names like Juul, Suorin, SMOK, Fin, NJOY, Blu, e-Go, or Vuse. Some look like cigarettes, and others look like small boxes, pens, or pipes. From now on, we will refer to these products as e-cigarettes. E-cigarettes heat up a liquid to aerosolize it so people can inhale it. Although some e-liquid does not contain nicotine, we are only interested in e-cigarettes that DO contain nicotine. Please answer the following questions about e-cigarettes that contain nicotine." Response options are, "Much less harmful," "Somewhat less harmful," "Not less or more harmful," "Somewhat more harmful," "Much more harmful." Response options were dichotomized to low relative harm perceptions (much less harmful, somewhat less harmful) and high relative harm perceptions (much more harmful, somewhat more harmful, not less or more harmful).

    Baseline and up to 5 minutes after receiving the corrective message

  • Change in Relative Harm Beliefs Regarding NRT

    Participants will be shown a written description of NRT before answering questions about them: "The next questions are about nicotine replacement therapy (NRT). NRT is a medicine that is available as skin patches, chewing gum, nasal and oral sprays, inhalers, lozenges and tablets and delivers nicotine to the body. Nicotine replacement therapy is approved to help people quit smoking." Participants will also see a picture of these products with the description. Response options are, "Much less harmful," "Somewhat less harmful," "Not less or more harmful," "Somewhat more harmful," "Much more harmful." Response options were dichotomized to low relative harm perceptions (much less harmful, somewhat less harmful) and high relative harm perceptions (much more harmful, somewhat more harmful, not less or more harmful).

    Baseline and up to 5 minutes after receiving the corrective message

  • Change in Relative Harm Beliefs Regarding Very Low Nicotine Cigarettes

    Participants will be shown a written description of very low nicotine cigarettes before answering questions about them: "The next questions are about very low nicotine cigarettes. A very low nicotine cigarette is a tobacco cigarette that is still smoked but has the vast majority (95% or more) of the nicotine removed from it. The average regular cigarettes typically contains 12-13 mg of nicotine. A very low nicotine cigarette could have less than 1 mg of nicotine in it. Very low nicotine cigarettes do not contain enough nicotine to maintain a physiological addiction to nicotine. Quest and Moonlight are brands of very low nicotine cigarettes." Participants will also see a picture of these products with the description. Response options were dichotomized to low relative harm perceptions (much less harmful, somewhat less harmful) and high relative harm perceptions (much more harmful, somewhat more harmful, not less or more harmful).

    Baseline and up to 5 minutes after receiving the corrective message

  • Change in Inferential Beliefs Regarding Smokeless Tobacco

    Participants will be shown a written description of smokeless tobacco before answering questions about them: "The next questions are about smokeless tobacco. Smokeless tobacco like chewing, oral, or spit tobacco come as loose leaves, plugs, or twists of dried tobacco that may be flavored. It's chewed or placed between the cheek and gum or teeth. The user spits out (or swallows) the saliva that has soaked through the tobacco. Dissolvables are another type of product that dissolves in the mouth and can be sold as lozenges, strips, or sticks. Nicotine is absorbed through the mouth tissues." Participants will also see a picture of these products with the description. Response options were dichotomized to low relative harm perceptions (much less harmful, somewhat less harmful) and high relative harm perceptions (much more harmful, somewhat more harmful, not less or more harmful).

    Baseline and up to 5 minutes after receiving the corrective message

  • Change in Inferential Beliefs Regarding Cigarillos

    Participants will be shown a written description of smokeless tobacco before answering questions about them: "The next questions are about cigarillos. Cigarillos look like small versions of traditional cigars, but can be bought in packages of one or two. Cigarillos smoke is often inhaled, unlike cigar smoke which is often held in the mouth and then released. Cigarillos are often flavored. Swisher Sweets, White Owl, and Dutch Masters are common cigarillo brands.." Participants will also see a picture of these products with the description. Response options were dichotomized to low relative harm perceptions (much less harmful, somewhat less harmful) and high relative harm perceptions (much more harmful, somewhat more harmful, not less or more harmful).

    Baseline and up to 5 minutes after receiving the corrective message

  • Change in Beliefs About Intention to Switch Products

    The extent to which participants agree or disagree with the following statement: I would consider completely switching to a tobacco product that is not lit on fire rather than continuing to smoke cigarettes. Response options are a continuous scale from 0 "I do not agree at all" to 100, "I completely agree."

    Baseline and up to 5 minutes after receiving the corrective message

Study Arms (4)

Nicotine corrective control

ACTIVE COMPARATOR

A factual message about nicotine that does not contain a causal explanation for what actually causes tobacco-caused disease or an explanation for why the misperception that nicotine causes cancer may have come to be believed.

Behavioral: Coherent corrective messages

Nicotine corrective with causal explanation

EXPERIMENTAL

A factual message about nicotine that contain a causal explanation for what actually causes tobacco-caused disease: tar and chemicals created in tobacco smoke when tobacco is lit on fire.

Behavioral: Coherent corrective messages

Nicotine corrective with reason for misperception

EXPERIMENTAL

A factual message about nicotine that contains an explanation for why the misperception may have come to be believed: that health messaging often discuses nicotine and tobacco-caused disease at the same time and people incorrectly make the connection that nicotine causes cancer.

Behavioral: Coherent corrective messages

Nicotine corrective with both components of coherence

EXPERIMENTAL

A factual message about nicotine that contains both a causal explanation for what actually causes tobacco-caused disease and an explanation for why the misperception may have come to be believed.

Behavioral: Coherent corrective messages

Interventions

Participants will be randomized to one of four message conditions: condition 1 will not contain either component of the coherence; condition 2 will contain one element of coherence (a causal explanation for why the corrective information is accurate); condition 3 will contain the other element of coherence (an explanation for why the misinformation came to be believed); condition 4 will include both elements of coherence.

Nicotine corrective controlNicotine corrective with both components of coherenceNicotine corrective with causal explanationNicotine corrective with reason for misperception

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are established smokers (have smoked at least 100 cigarettes in their lifetime and currently smoke some or all days)
  • Are 21 years of age or older (the legal age of tobacco purchase in the US)
  • Have not completed the cognitive interview during message pre-testing.
  • Rate their agreement with the following statement as at least 50 out of 100: "To what extent do you agree with the following statement: The substance nicotine causes cancer."
  • Are registered with MTurk in the United States.
  • Have completed \>= 5,000 HIITs within the MTurk system
  • Have a HIIT approval rating of \>= 97%

You may not qualify if:

  • Are not established smokers
  • Are younger than 21 years of age
  • Participated in cognitive interviews during message pre-testing
  • Are not registered with MTurk in the US
  • Have completed \< 5,000 HIITS
  • Have a HIIT approval rating of \<97%
  • Rate their agreement with the following statement as less than 50 out of 100: "To what extent do you agree with the following statement: The substance nicotine causes cancer."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Limitations and Caveats

Smokers on MTurk are unlikely to be representative of US smokers. The nicotine misperception was measured on a continuous 0-100 scale and was able to detect smaller changes than the dichotomous relative harm perception outcome. Participants who reported believing nicotine causes cancer may accurately understand that nicotine indirectly causes disease because it keeps people exposed to carcinogens over time, resulting in misclassification.

Results Point of Contact

Title
Caitlin Weiger
Organization
Johns Hopkins Bloomberg School of Public Health

Study Officials

  • Meghan B Moran, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: Participants will be randomized to view one of four messages. The message conditions are as follows: condition 1 will not contain either component of coherence; condition 2 will contain one element of coherence (a causal explanation for why the corrective information is accurate); condition 3 will contain the other element of coherence (an explanation for why the misinformation came to be believed); condition 4 will include both elements of coherence.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2021

First Posted

November 22, 2021

Study Start

November 22, 2021

Primary Completion

January 30, 2022

Study Completion

August 1, 2022

Last Updated

March 12, 2024

Results First Posted

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Upon request, deidentified participant data collected during the study may be shared. Upon request, the PI may also share the study protocol, survey, and informed consent form. Data will be made available upon request beginning 3 months following publication of the final article from this study, with no end date. Data will be made available for analyses deemed appropriate by the study PI. Proposals should be directed to mmoran22@jhu.edu. Data requestors will need to sign a data access agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
3 months following publication of the final article from this study

Locations