Messages About Reduced Nicotine in Combusted Tobacco Products

Study Overview
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Brief Summary
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The investigators will conduct a message-exposure experiment with nationally representative samples of smokers, dual-users (cigarettes and e-cigarettes), and young adult non-smokers (aged 18-29). Experimental messages will address the reduction of nicotine in cigarettes. Participants will also complete a follow-up survey after 2 weeks, measuring their recall of the messages and behaviors since message exposure.

Detailed Description
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A national probability-based sample will be recruited to include 900 current exclusive smokers, 450 dual users, and 450 young adult (18-29) non-smokers, evenly split between men and women. The study will be conducted using a self-administered, online questionnaire via proprietary, web-assisted interviewing software. Participants are randomized to one of four conditions: reduced nicotine messages modified risk messages a combination of reduced nicotine message and modified risk message control messages with no cigarette-related content Participants will take part in two sessions: in session 1 (estimated at about 15 min) participants will see the messages and report immediate outcomes including risk perceptions. In session 2, which will take place 2 weeks after session 1, participants will complete a brief 5-minute survey measuring their recall of the messages and behaviors since message exposure.

Official Title
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Messages About Reduced Nicotine in Combusted Tobacco Products: An Online Randomized Controlled Trial

Conditions
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Health Communication, Smoking, Smoking, Tobacco, Smoking Behaviors, Risk Behavior

Intervention / Treatment
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* Behavioral: Reduced nicotine message exposure
* Behavioral: Modified risk message exposure
* Behavioral: Combined message exposure (reduced nicotine + modified risk)
* Behavioral: Control message exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being 18 years old or older: Belonging to one of three groups of participants; 900 current exclusive smokers, 450 dual users (cigarettes and e-cigarettes), and 450 young adult (18-29) non-smokers, evenly split between men and women. Enrolled in existing nationally representative panel where recruitment is based Exclusion Criteria: - None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced Nicotine Messages<br>Participants will receive messages with information about reduced nicotine cigarettes. | Behavioral: Reduced nicotine message exposure<br>* Participants will be shown two messages about harms of reduced nicotine cigarettes. The two messages will be drawn from a pool of five messages. The messages will communicate that reduced nicotine cigarettes will still have the rest of the harmful chemicals and cause diseases as the regular cigarettes, but they would make it easier to quit.<br>|
| Experimental: Modified Risk Messages<br>Participants will receive messages with information about e-cigarettes. | Behavioral: Modified risk message exposure<br>* Participants will be shown two messages about electronic cigarettes as an alternative to regular cigarettes. The two messages will be drawn from a pool of five messages. The messages will communicate that electronic cigarettes are less likely than regular cigarettes to cause severe diseases such as lung cancer.<br>|
| Experimental: Combined Message -- Reduced Nicotine + Modified Risk Exposure<br>Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. | Behavioral: Combined message exposure (reduced nicotine + modified risk)<br>* Participants will be shown two messages, one from the reduced nicotine message set and one modified risk message set.<br>|
| Other: Control<br>Participants will receive messages about bottled water which should have no impact on the outcomes of interest. | Behavioral: Control message exposure<br>* Participants will be shown two messages about drinking bottled water. These will be selected from a pool of five message. The messages display specific water products and describe hydration as a healthy activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived health risk of VLNCs (absolute) | Measured with a single item, assesses participant's perception of own risk of overall harm to health under conditions of smoking reduced nicotine cigarettes every day. Response options range from 1 (Not at all likely) to 5 (Extremely likely) and include Don't know | Immediately after exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest in trying reduced nicotine cigarettes | A single item measuring how interested a participant is in trying reduced nicotine cigarettes. Response options are from 1. not at all to 7. extremely and include Don't know. | Immediately after exposure | 
| Perceived health risk of VLNCs (absolute) at post-test | Measured with a single item, assesses participant's perception of own risk of overall harm to health under conditions of smoking reduced nicotine cigarettes every day. Response options range from 1 (Not at all likely) to 5 (Extremely likely) and include Don't know | Two weeks after exposure | 
| Intention to switch from cigarettes to electronic nicotine products | A single item measuring intention (during the next 6 months) to switch completely from cigarettes to electronic nicotine products. Response options are from 1. not at all likely to 7. extremely likely and include Don't know. | Immediately after exposure | 
| Perceived addictiveness of VLNCs | A single item measuring participants' perception of likelihood developing addiction to reduced nicotine cigarettes under conditions of smoking them every day. Response options are from 1. Not at all likely to 5. Extremely likely and include Don't know.' | Immediately after exposure | 
| VLNC Comparative Risk Perceptions | A single item measuring perceptions of comparative risk of smoking reduced nicotine cigarettes vs regular cigarettes. Response options are from 1.Much less harmful to 5. Much more harmful and include Don't know.' | Immediately after exposure | 
| VLNC Policy Support | A single item measuring support for the policy to reduce nicotine by 95% in all cigarettes. Response options are from 1. Strongly Oppose to 5. Strongly Support and include Don't know. | Immediately after exposure | 
| Perceived Message Effectiveness | A three-item scale measuring to what extent participants think the messages they saw discourage them from wanting to smoke, make smoking seem unpleasant, and make them concerned about health risks of smoking. Response options: Strongly Disagree (1) Neither Disagree nor Agree (4) Strongly Agree (7) | Immediately after exposure | 
| Smoking behavior | Single item measuring the average number of cigarettes smoked per day in the past two weeks. | Two weeks after exposure |