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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,230
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.
Participants will be exposed to control messages, such as advertisements for bottled water, during their weekly visits.
Georgia State university
Atlanta, Georgia, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGCigarettes per day
Number of cigarettes smoked per day (study and non-study cigarettes). * Averaged number of cigarettes smoked based on 7 days' daily logs submitted through text-based survey during the last week of the trial. * Response: integer indicating number per day.
Time frame: Week 4 of the trial (post randomization)
Use of other tobacco products
Amount of other combusted (LCCs) and noncombustible (e-cigarettes) products per day. * Averaged number of other tobacco products is based on 7 days' daily logs submitted through text-based survey during the last week of the trial. * Response: integer indicating number per day.
Time frame: Week 4 of the trial (post randomization)
Use of cessation medications
Use of nicotine replacement therapy or prescription cessation medications in the past 24 hours based on 7 days' daily logs submitted through text-based survey during the last week of the trial. This will be assessed using a multiple-choice question, allowing participants to select all NRT or prescription cessation medications used from a provided list of options.
Time frame: Week 4 of the trial (post randomization)
Forgoing cigarettes
One item measures number of times forgoing cigarettes when considering smoking in the past 24 hours based on daily logs submitted through text-based survey from baseline visit to the end of the trial. Response options are: 1 (Never), 2 (Once), 3 (A few times), and 4 (Lots of times), with higher scores representing a better outcome.
Time frame: Through study completion, up to 4 weeks
Making a quit attempt
One item measures whether participants have made an attempt to stop smoking (not smoking cigarettes for at least 24 hours) in the past week based on questionnaire completed at weekly in-person visits throughout the trial. Response options: 1 (yes), 2 (no), 3 (don't know).
Time frame: Through study completion, up to 4 weeks
Perceived risk of smoking VLNCs
One item measures perceived likelihood of overall harm to health under conditions of smoking VLNCs based on questionnaire completed at the week 4 visit. 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.
Time frame: Week 4 of the trial (post randomization)
Self-efficacy to quit
Multiple items assess perceptions about strength of confidence in own ability to quit smoking based on questionnaire completed at week 4 visit. Response options range from 1 (not at all) to 7 (extremely), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
Time frame: Week 4 of the trial (post randomization)
Intention to quit smoking
Multiple items assesses Intentions and motivation to quit smoking in the next month and 6 months based on questionnaire completed at week 4 visit. Response options range from 1 (not at all) to 7 (extremely), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
Time frame: Week 4 of the trial (post randomization)
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