Communicating About Nicotine Reduction in Cigarettes

Not Applicable

Not yet recruiting

• Conditions: Tobacco Products; Smoking Behavior; Cigarette Use

• Registration Number: NCT06787937
• Lead Sponsor: Georgia State University

Brief 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. 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:

1. treatment condition, where participants receive VLNCs during weekly visits and are exposed to messages about VLNCs and reduced nicotine policy.

2. 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 text messages with links to brief online surveys, sent each day at a time the participant chooses.

Study Timeline

• Study First Submitted: 2024-12-25
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Study Start: 2025-03-01
• Primary Completion: 2029-01-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1240

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnancy or lactation
• Member of the same household as a study subject
• Unwilling to use research cigarettes as part of the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cigarettes per day	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.

Secondary Outcome Measures

Name	Time	Method
Use of other tobacco products	Week 4 of the trial (post randomization)	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.
Use of cessation medications	Week 4 of the trial (post randomization)	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.
Forgoing cigarettes	Through study completion, up to 4 weeks	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.
Making a quit attempt	Through study completion, up to 4 weeks	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).
Perceived risk of smoking VLNCs	Week 4 of the trial (post randomization)	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.
Self-efficacy to quit	Week 4 of the trial (post randomization)	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.
Intention to quit smoking	Week 4 of the trial (post randomization)	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.

Trial Locations

Locations (2)

Georgia State university; 🇺🇸 Atlanta, Georgia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States