1240 Participants Needed

VLNC Messages for Smoking

Recruiting at 1 trial location
LP
Overseen ByLyudmila Popova, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Georgia State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the VLNC messages treatment for smoking cessation?

Text messaging interventions, like the VLNC messages, have shown promise in helping people quit smoking by increasing engagement and satisfaction, as seen in a study with Latino smokers where 30% achieved abstinence. Additionally, shorter, more direct messages have been effective in recruiting and helping people quit smoking.12345

Is it safe to use very low nicotine content (VLNC) cigarettes?

Research on very low nicotine content (VLNC) cigarettes shows they can reduce the number of cigarettes smoked and exposure to harmful substances, suggesting they are generally safe for use in humans.678910

How is the VLNC Messages treatment for smoking different from other treatments?

VLNC Messages for smoking is unique because it uses text messaging to deliver smoking cessation support, which can be more accessible and engaging for users compared to traditional methods. This approach allows for real-time interaction and personalized support, making it a novel option for those looking to quit smoking.511121314

Eligibility Criteria

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
See 2 more

Exclusion Criteria

Pregnancy or lactation
Member of the same household as a study subject
I am not willing to smoke research cigarettes.

Timeline

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

Treatment Details

Interventions

  • Control message
  • VLNC messages
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: VLNC with message campaignExperimental Treatment1 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 onlyExperimental Treatment1 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.

Find a Clinic Near You

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+

Findings from Research

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.
Adding spirometry, carbon monoxide, and pulmonary symptom results to smoking cessation counseling: a randomized trial.Risser, NL., Belcher, DW.[2022]
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.
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 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.
Sex differences in response to reduced nicotine content cigarettes.Vogel, RI., Hertsgaard, LA., Dermody, SS., et al.[2022]

References

Evaluation of alternate messages on an electronic message strip to recruit subjects to a smoking-cessation program. [2004]
A review of computer and Internet-based interventions for smoking behavior. [2022]
Adding spirometry, carbon monoxide, and pulmonary symptom results to smoking cessation counseling: a randomized trial. [2022]
Feasibility and Acceptability of a Culturally- and Linguistically-Adapted Smoking Cessation Text Messaging Intervention for Latino Smokers. [2021]
Combining Real-Time Ratings With Qualitative Interviews to Develop a Smoking Cessation Text Messaging Program for Primary Care Patients. [2023]
Sex differences in response to reduced nicotine content cigarettes. [2022]
Immediate Switching to Reduced Nicotine Cigarettes in a U.S.-Based Sample: The Impact on Cannabis Use and Related Variables at 20 Weeks. [2023]
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. [2020]
Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. [2022]
Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers With Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial. [2023]
Engagement and abstinence among users of a smoking cessation text message program for veterans. [2019]
Quit4hlth: a preliminary investigation of tobacco treatment with gain-framed and loss-framed text messages for quitline callers. [2022]
Adaptation and Assessment of a Text Messaging Smoking Cessation Intervention in Vietnam: Pilot Randomized Controlled Trial. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Suicide Prevention Referrals in a Mobile Health Smoking Cessation Intervention. [2022]