VLNC Messages for Smoking

Recruiting at 1 trial location

Overseen By Lyudmila Popova, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

Disqualifiers: Pregnancy, Lactation, Household member, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

1230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how messages about very low nicotine cigarettes (VLNCs) and related policies affect smoking habits and attitudes among adult smokers. Participants will receive either VLNCs with these messages or VLNCs with unrelated messages, such as water ads, to compare the effects. The trial targets current smokers who have smoked regularly in the past month and are open to trying new research cigarettes. The study involves weekly visits, surveys, and daily check-ins via text. As an unphased trial, it offers participants the opportunity to contribute to important research on smoking behaviors and potentially influence future public health policies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking behavior and the use of very low nicotine cigarettes.

What prior data suggests that this messaging campaign and use of VLNCs is safe for adult smokers?

Research has shown that very low nicotine cigarettes (VLNCs) are generally easy for people to use. One study found that those who smoked VLNCs smoked fewer cigarettes daily and experienced less craving compared to those who smoked regular cigarettes. This suggests that VLNCs might be less satisfying, which is intended due to their lower nicotine content.

Another study examined how people understood messages about VLNCs. It found that people recognized these cigarettes had less nicotine and did not mistakenly believe they were completely safe. Instead, they viewed them as a potential aid in reducing smoking.

Overall, using VLNCs and the information about them appears safe for users. Research has not shown any major negative effects, making them a possible option for those who want to smoke less. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VLNC (Very Low Nicotine Content) messages for smoking because they offer a fresh approach to reducing tobacco dependence. Unlike traditional treatments, which often focus on nicotine replacement or pharmaceutical aids like patches or gum, this approach leverages messaging about reduced nicotine content. The VLNC with message campaign arm not only provides VLNC cigarettes but also actively educates participants through various media formats about the benefits of reduced nicotine, potentially enhancing motivation and awareness. This dual approach—combining product exposure with targeted messaging—could lead to more effective smoking cessation strategies by addressing both the physical and psychological aspects of smoking addiction.

What evidence suggests that this trial's treatments could be effective for reducing cigarette use?

Research has shown that messages about very low nicotine cigarettes (VLNCs) can change perceptions of smoking. One study found that these messages can reduce the belief that VLNCs are safer than regular cigarettes. This change is crucial for helping smokers cut down or quit. In this trial, participants in the "VLNC with message campaign" arm will receive VLNCs and be exposed to messaging about VLNCs and reduced nicotine policy. Another study demonstrated that specific messages can decrease false beliefs about the safety of reduced nicotine cigarettes. These findings suggest that using VLNCs along with clear messages can help reduce smoking by correcting misunderstandings and encouraging quitting. Meanwhile, participants in the "VLNC only" arm will receive VLNCs but will only be exposed to control messages, such as advertisements for bottled water. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adult smokers, including those with recent serious psychological distress or low socioeconomic status. Participants must be willing to attend weekly study visits and complete daily surveys via text message.

Inclusion Criteria

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)

I am 21 years old or older.

Can speak, read, and write in English

Exclusion Criteria

Pregnancy or lactation

Member of the same household as a study subject

I am not willing to smoke research cigarettes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Participants complete a baseline survey, provide expired breath CO sample, and receive a 1-week supply of full nicotine cigarettes

1 week

1 visit (in-person)

Randomization

Participants are randomized into treatment or control groups and receive a 14-day supply of VLNCs

2 weeks

1 visit (in-person)

Treatment

Participants attend weekly visits to complete questionnaires, provide expired CO samples, and receive VLNCs with or without messages

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for smoking behavior and attitudes after the treatment phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control message
• VLNC messages

Trial Overview The study tests if a messaging campaign about reduced nicotine cigarettes affects smoking behavior when combined with using very low nicotine cigarettes (VLNCs). It compares the effects of VLNCs with messages versus VLNCs alone.

How Is the Trial Designed?

Group I: VLNC with message campaign Experimental Treatment 1 Intervention

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.

Group II: VLNC only Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

University of South Carolina

Collaborator

Trials

233

Recruited

122,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Automated mobile health programs like SmokefreeVET effectively support smoking cessation through text messaging, with nearly 7% of enrollees accessing suicide prevention resources.

Incorporating suicide prevention hotline referrals into smoking cessation mHealth interventions is recommended due to the significant overlap between smoking and suicide risk, enhancing the support provided to users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide Prevention Referrals in a Mobile Health Smoking Cessation Intervention. Christofferson, DE., Hamlett-Berry, K., Augustson, E.[2022]

In a study involving 729 participants, switching to very low nicotine content cigarettes (VLNCs) led to significant reductions in certain toxicant exposures, particularly in those who only smoked cigarettes, while co-users of cannabis and cigarettes showed less reduction in non-tobacco-specific toxicants.

Co-users of cannabis and cigarettes who switched to VLNCs experienced similar reductions in cigarette consumption and tobacco-specific exposure as cigarette-only users, but they were at a higher risk for increased exposure to harmful substances and a slight increase in cannabis use over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Switching to Reduced Nicotine Cigarettes in a U.S.-Based Sample: The Impact on Cannabis Use and Related Variables at 20 Weeks. Meier, E., Rubin, N., Dermody, SS., et al.[2023]

In a 33-week study involving 245 adult daily smokers, those who switched to very low nicotine content (VLNC) cigarettes showed a 50% reduction in nicotine levels and smoked fewer cigarettes per day compared to those who continued with usual nicotine content (UNC) cigarettes.

However, the VLNC group experienced higher attrition rates, indicating that some smokers struggled to adapt to the lower nicotine levels, suggesting that additional support or nicotine alternatives may be necessary for successful transition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers With Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial. Krebs, NM., Zhu, J., Wasserman, E., et al.[2023]

A text messaging (SMS) program developed for adult smokers in primary care received high ratings for clarity and usefulness, with 96% of messages rated positively by participants.

Patients expressed a desire for personalized messages, inclusion of e-cigarette information, and graphics, while also identifying gaps in knowledge about nicotine replacement therapy (NRT) safety and effectiveness, highlighting the importance of tailoring interventions to meet smokers' needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Real-Time Ratings With Qualitative Interviews to Develop a Smoking Cessation Text Messaging Program for Primary Care Patients. Kruse, G., Park, ER., Shahid, NN., et al.[2023]

In a trial with 68 adult smokers, transitioning to very low nicotine content (VLNC) cigarettes combined with nicotine patches led to a greater reduction in nicotine dependence compared to simply reducing the number of cigarettes smoked per day.

Participants using VLNC cigarettes experienced a mean decrease in nicotine dependence of 1.0 Z-score, while those reducing their cigarette count had a decrease of only 0.5 Z-score, indicating that VLNC may be a more effective strategy for reducing dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of switching to very low nicotine content cigarettes plus nicotine patch versus reducing daily cigarette consumption plus nicotine patch to decrease dependence: an exploratory randomized trial. Klemperer, EM., Hughes, JR., Callas, PW., et al.[2020]

The SmokefreeVET text messaging program, designed for veterans, showed that 13% of users achieved smoking abstinence after five weeks, with higher success rates among those who were highly engaged in the program.

Users who combined SmokefreeVET with smoking cessation medications were significantly more likely to quit smoking, with an odds ratio of 9.01, highlighting the importance of medication in enhancing the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement and abstinence among users of a smoking cessation text message program for veterans. Christofferson, DE., Hertzberg, JS., Beckham, JC., et al.[2019]

In a pilot study involving 600 smokers, those receiving gain-framed text messages (focused on the benefits of quitting) made more quit attempts (98%) compared to those receiving loss-framed messages (93%).

While the overall smoking cessation rates at 30 weeks were similar between the gain-framed (17%) and loss-framed (15%) groups, the gain-framed messages appeared to encourage more proactive quitting behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quit4hlth: a preliminary investigation of tobacco treatment with gain-framed and loss-framed text messages for quitline callers. Rojewski, AM., Duncan, LR., Carroll, AJ., et al.[2022]

In a study of 235 participants, very low nicotine content (VLNC) cigarettes combined with a nicotine patch were more effective in reducing cigarette use and withdrawal symptoms in males compared to females.

Females showed a higher likelihood of quitting smoking when using VLNC cigarettes, while males had better success quitting with the nicotine patch alone, suggesting that sex differences play a significant role in the effectiveness of smoking cessation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences in response to reduced nicotine content cigarettes. Vogel, RI., Hertsgaard, LA., Dermody, SS., et al.[2022]

Smoking very low nicotine content (VLNC) cigarettes for 6 weeks led to greater reductions in nicotine exposure, which was associated with higher rates of smoking abstinence one month later among 112 adult daily smokers.

The study found that lower nicotine yield in VLNC cigarettes and reduced use of normal nicotine content cigarettes enhanced the effectiveness of nicotine reduction strategies, suggesting that maximizing nicotine reduction could support smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. Dermody, SS., Donny, EC., Hertsgaard, LA., et al.[2022]

A study involving 90 smokers showed that providing personalized feedback on exhaled carbon monoxide and lung function significantly increased the likelihood of quitting smoking, with 40% of those receiving the intervention reporting cessation compared to only 16% in the control group.

At the 12-month mark, 33% of the intervention group achieved verified smoking cessation through carbon monoxide testing, compared to just 10% in the control group, highlighting the effectiveness of personalized motivational strategies in smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding spirometry, carbon monoxide, and pulmonary symptom results to smoking cessation counseling: a randomized trial. Risser, NL., Belcher, DW.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10043050/

Messaging about very low nicotine cigarettes (VLNCs) to ... The present study suggests how messages about VLNCs may enhance the effectiveness of the policy by increasing motivation to quit among those who ...

2. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/early/2024/04/25/tc-2023-058556

Independent and combined effects of very low nicotine ... VLNC messages reduced the misperception that VLNCs are less harmful than cigarettes, but adding messages about e-cigarettes did not enhance desired outcomes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524002717

Correcting misperceptions about very low nicotine ... Compared to the no-message control, the VLNC message condition showed lower nicotine risk perception for all participants, lower misbelief in VLNC safety for ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06787937?term=communicating%20risk&viewType=Table&rank=7

Communicating About Nicotine Reduction in Cigarettes Participants will be exposed to messaging about VLNCs and reduced nicotine policy through multiple formats, including inserts placed in cigarette packs, printed ...

5. nature.com nature.com/articles/s41598-025-04050-z

Targeting three United States priority populations of people ... Targeted messages resulted in significantly fewer reduced nicotine content cigarette false beliefs as compared to standard messages, t(129.66) = ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9699899/

Effects of Very Low Nicotine Content Cigarettes on ... Those assigned to VLNC cigarettes had lower CPD, CO levels and craving, and reported lower cigarette satisfaction and reward than those assigned to NNC ...

7. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/33/3/325

Messaging about very low nicotine cigarettes (VLNCs) to ... Outcomes were selection of messages that generated the most positive attitude towards reduced nicotine policy, the greatest perceived harmfulness of VLNCs ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06787937

Communicating About Nicotine Reduction in Cigarettes Participants will be exposed to messaging about VLNCs and reduced nicotine policy through multiple formats, including inserts placed in cigarette packs, printed ...

9. formative.jmir.org formative.jmir.org/2024/1/e63035

Public Perceptions of Very Low Nicotine Content on Twitter Our results showed that Twitter users were more likely to think that VLNC can help smoking or vaping cessation than that VLNC is not a good ...