NCT05506046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,901

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 12, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 28, 2024

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

August 16, 2022

Results QC Date

February 13, 2024

Last Update Submit

August 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Immediately after exposure

Secondary Outcomes (8)

  • Interest in Trying Reduced Nicotine Cigarettes

    Immediately after exposure

  • Intention to Switch From Cigarettes to Electronic Nicotine Products

    Immediately after exposure

  • Perceived Addictiveness of VLNCs

    Immediately after exposure

  • VLNC Comparative Risk Perceptions

    Immediately after exposure

  • VLNC Policy Support

    Immediately after exposure

  • +3 more secondary outcomes

Study Arms (4)

Reduced Nicotine Messages

EXPERIMENTAL

Participants will receive messages with information about reduced nicotine cigarettes.

Behavioral: Reduced nicotine message exposure

Modified Risk Messages

EXPERIMENTAL

Participants will receive messages with information about e-cigarettes.

Behavioral: Modified risk message exposure

Combined Message -- Reduced Nicotine + Modified Risk Exposure

EXPERIMENTAL

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

Behavioral: Combined message exposure (reduced nicotine + modified risk)

Control

OTHER

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

Behavioral: Control message exposure

Interventions

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.

Reduced Nicotine Messages

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.

Modified Risk Messages

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

Combined Message -- Reduced Nicotine + Modified Risk 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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30302, United States

Location

Related Publications (1)

  • Pei D, Reynolds RM, Ntansah CA, Hackworth EE, Henderson KC, Yang B, Duong HT, Ashley DL, Thrasher JF, Popova L. Independent and combined effects of very low nicotine cigarette messages and e-cigarette messages: a randomised clinical trial. Tob Control. 2025 Dec 19;34(e1):e48-e56. doi: 10.1136/tc-2023-058556.

MeSH Terms

Conditions

SmokingTobacco SmokingRisk-Taking

Condition Hierarchy (Ancestors)

BehaviorTobacco Use

Results Point of Contact

Title
Lyudmila Popova
Organization
Georgia State University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

October 12, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

August 28, 2024

Results First Posted

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations