Communicating About Nicotine Reduction in Cigarettes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorGeorgia State University
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnancy or lactation
Member of the same household as a study subject
Unwilling to use research cigarettes as part of the trial
Trial design
Design model
Parallel
Treatments tested in this trial
VLNC messages
BehavioralParticipants 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 message
BehavioralParticipants will be exposed to control messages, such as advertisements for bottled water, during their weekly visits.
Treatment groups
1,230 Participants
are divided into 2 treatment groupsGroup A: VLNC with message campaignExperimental treatment 1 intervention
Group B: VLNC onlyOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 4 of the trial (post randomization)Secondary outcomes
1
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.
Time frame
Week 4 of the trial (post randomization)2
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.
Time frame
Week 4 of the trial (post randomization)3
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.
Time frame
Through study completion, up to 4 weeks4
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).
Time frame
Through study completion, up to 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Georgia State University
Lead sponsor
Emory University
Collaborator
University of South Carolina
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov