Messages About Reduced Nicotine in Combusted Tobacco Products

NCT ID: NCT05506046

Last Updated: 2024-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1901 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2023-02-28

Brief Summary

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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

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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.

Conditions

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Health Communication Smoking Smoking, Tobacco Smoking Behaviors Risk Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reduced Nicotine Messages

Participants will receive messages with information about reduced nicotine cigarettes.

Group Type EXPERIMENTAL

Reduced nicotine message exposure

Intervention Type BEHAVIORAL

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 Messages

Participants will receive messages with information about e-cigarettes.

Group Type EXPERIMENTAL

Modified risk message exposure

Intervention Type BEHAVIORAL

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 -- Reduced Nicotine + Modified Risk Exposure

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

Group Type EXPERIMENTAL

Combined message exposure (reduced nicotine + modified risk)

Intervention Type BEHAVIORAL

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

Control

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

Group Type OTHER

Control message exposure

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgia State University

OTHER

Sponsor Role lead

Responsible Party

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Lyudmila Popova

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Georgia State University

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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. 2024 Apr 25:tc-2023-058556. doi: 10.1136/tc-2023-058556. Online ahead of print.

Reference Type DERIVED
PMID: 38664002 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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H22639

Identifier Type: -

Identifier Source: org_study_id

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