Communicating About Nicotine Reduction in Cigarettes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-11

Study Completion Date

2029-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to learn how a messaging campaign about reduced nicotine cigarettes and policy, combined with the use of very low nicotine cigarettes (VLNCs), affects smoking behavior and attitudes among adult smokers. The study also aims to assess the efficacy of the messages in different populations, including smokers with past-month serious psychological distress (SPD), low socioeconomic status (SES), and those in neither category.

The primary hypothesis is: exposure to messages in combination with VLNC use will lead to less cigarettes use compared to VLNCs without messages.

Researchers will compare: The effects of receiving VLNCs with messages (treatment group) to receiving VLNCs without messages (control group).

Participants will: Complete a baseline survey and be randomly assigned to one of two groups: treatment (VLNCs + messages) or control (VLNCs only). Attend weekly study visits for surveys, breath samples, and receive supply of VLNCs , either with or without the messaging campaign. Complete brief daily surveys through text messages.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Messages About Reduced Nicotine in Combusted Tobacco Products

NCT05506046

Health Communication Smoking Smoking, Tobacco +2 more

COMPLETED NA

Enhancing Source Credibility in Tobacco Regulatory Communications

NCT03339206

Cigarette Smoking Behavior

COMPLETED NA

Responses to Message Source and Presentation Using Psychophysiology

NCT06269003

Vaping

COMPLETED NA

Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices

NCT04740008

Smoking Cigarette

COMPLETED EARLY_PHASE1

Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes

NCT04974489

Tobacco Use, Cigarette Use

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, open label, controlled, two-site study to test the efficacy of a messaging campaign about reduced nicotine cigarettes and policy in combination with the use of very low nicotine cigarettes (VLNCs). Smokers from three groups: with past-month serious psychological distress (SPD), with low socioeconomic status (SES), and in neither category will complete a 1-week baseline and a 4-week study; they will be randomized to one of two conditions:

1. treatment condition, where participants receive VLNCs during weekly visits and are exposed to messages about VLNCs and reduced nicotine policy.
2. control condition, where participants receive VLNCs without exposure to messages.

Message intervention: Messages about VLNCs and reduced nicotine policy will be professionally developed as full-color inserts (small leaflets that will be inserted into cigarette packs given to participants), print ads, and videos. At each weekly visit, participants will see 3-6 messages about VLNCs and reduced nicotine policy (in the treatment condition) or, in the control condition, 3-6 messages unrelated to tobacco (ads for bottled water, which are neutral messages that are unlikely to affect tobacco-related perceptions or behavior). Participants in the treatment conditions will also have inserts in their VLNC cigarette packs.

Baseline visit: Participants will complete a baseline survey, provide expired breath Carbon Monoxide (CO) sample, and receive a 1-week supply of the study cigarettes (full nicotine).

Randomization visit: Participants will be randomized into either the treatment (VLNCs + messages) or control (VLNCs only) condition. Participants will complete questionnaires, provide an expired CO sample, and receive a 14-day supply of VLNCs (either with or without the messages, according to the assigned condition).

Weekly visits: Starting one week after the randomization visit, participants will complete 4 weekly visits at their designated study site. At each visit, they will complete questionnaires, provide an expired CO sample, and receive a 14-day supply of VLNCs (with or without the messages, according to the assigned condition).

Daily logs: Throughout the baseline and 4 weekly study periods, participants will receive daily text messages with links to brief online surveys.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Products Smoking Behavior Cigarette Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VLNC with message campaign

Participants in this arm will receive VLNCs during weekly visits and be exposed to messaging about VLNCs and reduced nicotine policy through multiple formats, including inserts placed in cigarette packs, printed advertisements, and videos presented during weekly visits.

Group Type EXPERIMENTAL

VLNC messages

Intervention Type BEHAVIORAL

Participants will be exposed to messaging about VLNCs and reduced nicotine policy through multiple formats, including inserts placed in cigarette packs, printed advertisements, and video materials presented during their weekly visits.

VLNC only

Participants in this arm will receive VLNCs during weekly visits but will not receive any messaging related to cigarettes or reduced nicotine policy. Instead, they will only be exposed to control messages, such as advertisements for bottled water, during weekly visits.

Group Type OTHER

Control message

Intervention Type BEHAVIORAL

Participants will be exposed to control messages, such as advertisements for bottled water, during their weekly visits.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VLNC messages

Participants will be exposed to messaging about VLNCs and reduced nicotine policy through multiple formats, including inserts placed in cigarette packs, printed advertisements, and video materials presented during their weekly visits.

Intervention Type BEHAVIORAL

Control message

Participants will be exposed to control messages, such as advertisements for bottled water, during their weekly visits.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 21+ years
* Current smoker (self-report as having smoked 100 cigarettes in their lifetime and currently smoking on 27+ days out of past 30, expired breath carbon monoxide \[CO\] ≥6ppm to assess regular smoking)
* Can speak, read, and write in English
* Available for period of study
* Willing to try novel research cigarettes