Tobacco ProductsNCT06787937
Communicating About Nicotine Reduction in Cigarettes
A study testing VLNC messages in people with Tobacco Products and Smoking Behavior, run by Georgia State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Products, Smoking Behavior, Cigarette Use
- What is being tested?
- VLNC messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,230 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2025to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or lactation
- Member of the same household as a study subject
- Unwilling to use research cigarettes as part of the trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Georgia State university
Atlanta, Georgia, 30303
Lyudmila Popova, Ph.D., 404-413-9338, lpopova1@gsu.edu
- Recruiting
Emory University
Atlanta, Georgia, 30322
Nicholas Giordano, Ph.D., 404-727-7980, nicholas.a.giordano@emory.edu
About this study
Official title: Communicating About Nicotine and Differential Risks of Tobacco Products in Priority Populations
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.
Read more
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.
Read the 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:
- treatment condition, where participants receive VLNCs during weekly visits and are exposed to messages about VLNCs and reduced nicotine policy.
- 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
- Tobacco Products, Smoking Behavior, Cigarette Use
- Being tested
- VLNC messages, Control message
- Keywords
- smoking, health communication, very low nicotine cigarettes
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLNC messagesBehavioural
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.
Control messageBehavioural
Participants will be exposed to control messages, such as advertisements for bottled water, during their weekly visits.
| Study group | Role | What they receive |
|---|---|---|
| VLNC with message campaign | Experimental | 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. Receives: Behavioral: VLNC messages |
| VLNC only | Other | 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. Receives: Behavioral: Control message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarettes 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.
Measured: Week 4 of the trial (post randomization)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4 of the trial (post randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start11 Sep 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco ProductsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, University of South Carolina, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lyudmila Popova, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787937
- Sponsor's protocol ID
- H25318
- Other IDs
- R01CA239308
- Status last verified
- Oct 2025
- First submitted
- 25 Dec 2024
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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: 10.1186/s13063-025-09216-8.
PubMed 41250122
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating About Nicotine and Differential Risks of Tobacco Products in Priority Populations
- ClinicalTrials.gov ID
- NCT06787937
- Acronym / sponsor ID
- H25318
- Conditions
- Tobacco Products, Smoking Behavior, Cigarette Use
- Keywords
- smoking, health communication, very low nicotine cigarettes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,230 participants (estimated)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Emory University, University of South Carolina, National Cancer Institute (NCI)
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- treatment condition, where participants receive VLNCs during weekly visits and are exposed to messages about VLNCs and reduced nicotine policy.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLNC with message campaign | Experimental | Behavioral: VLNC messagesParticipants 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. |
| VLNC only | Other | Behavioral: Control messageParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy or lactation
- Member of the same household as a study subject
- Unwilling to use research cigarettes as part of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLNC messagesParticipants 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. | Behavioural | VLNC with message campaign |
| Control messageParticipants will be exposed to control messages, such as advertisements for bottled water, during their weekly visits. | Behavioural | VLNC only |
Primary outcome
Cigarettes per day
Time frame: Week 4 of the trial (post randomization)
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.
7 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Derived from this study: PubMed 41250122Pei 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: 10.1186/s13063-025-09216-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VLNC messages in people with Tobacco Products and Smoking Behavior, run by Georgia State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lyudmila Popova, Ph.D. (404-413-9338, lpopova1@gsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarettes per day (time frame: Week 4 of the trial (post randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.