Clinical trial NCT05506046: Messages About Reduced Nicotine in Combusted Tobacco Products
Official title: Messages About Reduced Nicotine in Combusted Tobacco Products: An Online Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Communication
Smoking
Smoking, Tobacco
Smoking Behaviors
Risk Behavior
Lead sponsor: Georgia State University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 1901
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Health Risk of VLNCs (Absolute)
timeFrame: Immediately after exposure
Secondary outcomes:
measure: Interest in Trying Reduced Nicotine Cigarettes
timeFrame: Immediately after exposure
measure: Intention to Switch From Cigarettes to Electronic Nicotine Products
timeFrame: Immediately after exposure
measure: Perceived Addictiveness of VLNCs
timeFrame: Immediately after exposure
measure: VLNC Comparative Risk Perceptions
timeFrame: Immediately after exposure
measure: VLNC Policy Support
timeFrame: Immediately after exposure
measure: Perceived Message Effectiveness
timeFrame: Immediately after exposure
measure: Perceived Health Risk of VLNCs (Absolute) at Post-test
timeFrame: Two weeks after exposure
measure: Smoking Behavior
timeFrame: Two weeks after exposure
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
References: