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Completed

NCT Number: NCT05506046

Messages About Reduced Nicotine in Combusted Tobacco Products

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30302, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reduced nicotine message exposure

Behavioral

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.

Modified risk message exposure

Behavioral

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.

Combined message exposure (reduced nicotine + modified risk)

Behavioral

Participants will be shown two messages, one from the reduced nicotine message set and one modified risk message set.

Control message exposure

Behavioral

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.

Primary outcomes

  1. Perceived Health Risk of VLNCs (Absolute)

    Time frame: Immediately after exposure

    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), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.

Secondary outcomes

  1. Interest in Trying Reduced Nicotine Cigarettes

    Time frame: Immediately after exposure

    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), with higher scores representing a worse outcome. An additional option, "Don't know", is also provided.

  2. Intention to Switch From Cigarettes to Electronic Nicotine Products

    Time frame: Immediately after exposure

    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), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.

  3. Perceived Addictiveness of VLNCs

    Time frame: Immediately after exposure

    A single item measuring participants' perception of likelihood of 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), with higher scores representing a worse outcome. An additional option, "Don't know", is also provided.

  4. VLNC Comparative Risk Perceptions

    Time frame: Immediately after exposure

    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), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.

  5. VLNC Policy Support

    Time frame: Immediately after exposure

    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), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.

  6. Perceived Message Effectiveness

    Time frame: Immediately after exposure

    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: from 1 (Disagree) to 4 (Neither Disagree nor Agree) to 7 (Strongly Agree).

    Higher scores represent a better outcome. The final perceived message effectiveness score is the mean of the response to the three items.

  7. Perceived Health Risk of VLNCs (Absolute) at Post-test

    Time frame: Two weeks after exposure

    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), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.

  8. Smoking Behavior

    Time frame: Two weeks after exposure

    Single item measuring the average number of cigarettes smoked per day in the past two weeks.

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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