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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05129592
Other study ID # 00015120A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2021
Est. completion date August 1, 2022

Study information

Verified date March 2024
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 193
Est. completion date August 1, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years to 99 Years
Eligibility Inclusion Criteria: - 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% Exclusion Criteria: - 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."

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Coherent corrective messages
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.

Locations

Country Name City State
United States Johns Hopkins Bloomberg School of Public Health Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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