Messages About Reduced Nicotine in Combusted Tobacco Products

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05506046
• Other study ID #: H22639
• Status: Completed
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: Georgia State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Smoking behavior	Single item measuring the average number of cigarettes smoked per day in the past two weeks.	Two weeks after exposure