Messages About Reduced Nicotine in Combusted Tobacco Products: An Online RCT

Sponsor
Georgia State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05506046
Collaborator
(none)
1,800
4
2.3

Study Details

Study Description

Brief Summary

We 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Reduced nicotine message exposure
  • Behavioral: Modified risk message exposure
  • Behavioral: Combined message exposure (reduced nicotine + modified risk)
  • Behavioral: Control message exposure
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Messages About Reduced Nicotine in Combusted Tobacco Products: An Online Randomized Controlled Trial
Anticipated Study Start Date :
Aug 22, 2022
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Reduced Nicotine Messages

Participants will receive messages with information about reduced nicotine cigarettes.

Behavioral: Reduced nicotine message exposure
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.

Experimental: Modified Risk Messages

Participants will receive messages with information about e-cigarettes.

Behavioral: Modified risk message exposure
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.

Experimental: Combined Message -- Reduced Nicotine + Modified Risk Exposure

Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes.

Behavioral: Combined message exposure (reduced nicotine + modified risk)
Participants will be shown two messages, one from the reduced nicotine message set and one modified risk message set.

Other: Control

Participants will receive messages about bottled water which should have no impact on the outcomes of interest.

Behavioral: Control message exposure
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.

Outcome Measures

Primary Outcome Measures

  1. Perceived health risk of VLNCs (absolute) [Immediately after exposure]

    Item asks: If you were to smoke reduced nicotine cigarettes every day, how likely is it that they would harm your overall health? Response option are: 1. Not at all likely 2. Slightly likely 3. Somewhat likely 4. Very likely 5. Extremely likely 8. Don't know

Secondary Outcome Measures

  1. Interest in trying reduced nicotine cigarettes [Immediately after exposure]

    Item asks: How interested are you in trying reduced nicotine cigarettes? Response options are: 1. not at all 2 3 4 5 6 7. extremely 8. Don't know

  2. Perceived health risk of VLNCs (absolute) [Two weeks after exposure]

    Item asks: If you were to smoke reduced nicotine cigarettes every day, how likely is it that they would harm your overall health? Response option are: 1. Not at all likely 2. Slightly likely 3. Somewhat likely 4. Very likely 5. Extremely likely 8. Don't know

  3. Intention to switch from cigarettes to electronic nicotine products [Immediately after exposure]

    Item asks: At any time during the next 6 months, do you think you will switch completely from cigarettes to electronic nicotine products? Response options: 1. not at all likely 2 3 4 5 6 7. extremely likely 8. Don't know

  4. Perceived addictiveness of VLNCs [Immediately after exposure]

    Item states: If you were to smoke reduced nicotine cigarettes every day, how likely is it that you would get addicted? Response options: 1. Not at all likely 2. Slightly likely 3. Somewhat likely 4. Very likely 5. Extremely likely 8. Don't know

  5. VLNC Comparative Risk Perceptions [Immediately after exposure]

    Item states: Compared to smoking regular cigarettes, how harmful is smoking reduced nicotine cigarettes? Response options: 1. Much less harmful 2. Less harmful 3. Equally harmful 4. More harmful 5. Much more harmful 8. Don't know

  6. VLNC Policy Support [Immediately after exposure]

    Item states: Think about the policy to reduce nicotine by 95% in all cigarettes. How much do you support or oppose this policy? Response options: 1. Strongly Oppose 2. Oppose 3. Neither Support nor Oppose 4. Support 5. Strongly Support 8. Don't know

  7. Perceived Message Effectiveness - smoking motivation [Immediately after exposure]

    Item states: These messages discourage me from wanting to smoke. Response options: Strongly Disagree (1) Neither Disagree nor Agree (4) Strongly Agree (7)

  8. Smoking behavior [Two weeks after exposure]

    Item states: In the PAST TWO WEEKS, on average how many cigarettes did you smoke per day? Response options: [integer indicating number per day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Being 18 years old or older:

  • We recruit 3 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Georgia State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lyudmila Popova, Associate Professor, Georgia State University
ClinicalTrials.gov Identifier:
NCT05506046
Other Study ID Numbers:
  • H22639
First Posted:
Aug 18, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022