Messages About Reduced Nicotine in Combusted Tobacco Products

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Risk Behavior; Smoking, Tobacco; Smoking Behaviors; Health Communication
• Intervention / Treatment: Behavioral: Reduced nicotine message exposure; Behavioral: Modified risk message exposure; Behavioral: Combined message exposure (reduced nicotine + modified risk); Behavioral: Control 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.

• Study Type: Interventional
• Enrollment (Actual): 1800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30302
      • Georgia State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Georgia State University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: H22639

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No