Communicating About Nicotine Reduction in Cigarettes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VLNC messages, Control message.
- Who it may be relevant to
- Registry conditions: Tobacco Products, Smoking Behavior, Cigarette Use. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Communicating About Nicotine and Differential Risks of Tobacco Products in Priority Populations
Overview
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 daily text messages with links to brief online surveys.
Interventions
- Behavioral 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. - Behavioral Control message
Participants will be exposed to control messages, such as advertisements for bottled water, during their weekly visits.
Primary outcome measures
- Cigarettes per day [Time frame: Week 4 of the trial (post randomization)]
Secondary outcome measures (7)
- Use of other tobacco products [Time frame: Week 4 of the trial (post randomization)]
- Use of cessation medications [Time frame: Week 4 of the trial (post randomization)]
- Forgoing cigarettes [Time frame: Through study completion, up to 4 weeks]
- Making a quit attempt [Time frame: Through study completion, up to 4 weeks]
- Perceived risk of smoking VLNCs [Time frame: Week 4 of the trial (post randomization)]
- Self-efficacy to quit [Time frame: Week 4 of the trial (post randomization)]
- Intention to quit smoking [Time frame: Week 4 of the trial (post randomization)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Georgia State university — Atlanta
- Emory University — Atlanta
Publications
- Pei D, Juris A, Nkansah P, Thrasher JF, Giordano NA, Henderson KC, Spears CA, Ashley DL, Mallory VC, Adeniji FP, Foster JD, Ni W, Kodriati N, Ogunnaike A, Pechacek TF, Kirpich A, Popova L. Nicotine Intervention and Communication for Empowering Reduction (NICER): study protocol for a randomized controlled trial among priority populations of people who smoke. Trials. 2025 Nov 17;26(1):514. doi: 10.1 PMID 41250122
Identifiers
NCT: NCT06787937 · H25318 · R01CA239308