Clinical trial NCT06787937: Communicating About Nicotine Reduction in Cigarettes
Official title: Communicating About Nicotine and Differential Risks of Tobacco Products in Priority Populations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tobacco Products
Smoking Behavior
Cigarette Use
Keywords: smoking
health communication
very low nicotine cigarettes
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Emory University
name: University of South Carolina
name: National Cancer Institute (NCI)
First posted: 2025-01-22
Enrollment: 1240
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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 text messages with links to brief online surveys, sent each day at a time the participant chooses.

Eligibility criteria: 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

Exclusion Criteria:

* Pregnancy or lactation
* Member of the same household as a study subject
* Unwilling to use research cigarettes as part of the trial

Primary outcomes:
measure: Cigarettes per day
timeFrame: Week 4 of the trial (post randomization)
Secondary outcomes:
measure: Use of other tobacco products
timeFrame: Week 4 of the trial (post randomization)
measure: Use of cessation medications
timeFrame: Week 4 of the trial (post randomization)
measure: Forgoing cigarettes
timeFrame: Through study completion, up to 4 weeks
measure: Making a quit attempt
timeFrame: Through study completion, up to 4 weeks
measure: Perceived risk of smoking VLNCs
timeFrame: Week 4 of the trial (post randomization)
measure: Self-efficacy to quit
timeFrame: Week 4 of the trial (post randomization)
measure: Intention to quit smoking
timeFrame: Week 4 of the trial (post randomization)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State university
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References: