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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA239308 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| University of South Carolina | OTHER |
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLNC messages | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarettes per day | Number of cigarettes smoked per day (study and non-study cigarettes).
| Week 4 of the trial (post randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| Use of other tobacco products | Amount of other combusted (LCCs) and noncombustible (e-cigarettes) products per day.
| Week 4 of the trial (post randomization) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lyudmila Popova, Ph.D. | Contact | 404-413-9338 | lpopova1@gsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State university | Recruiting | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41250122 | Derived | 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. |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Control message | Behavioral | Participants will be exposed to control messages, such as advertisements for bottled water, during their weekly visits. |
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| 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. | 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. | 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). | 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. | 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. | 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. | Week 4 of the trial (post randomization) |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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