Recruiting

VLNCs with Messages

Sponsor:

Georgia State University

Code:

NCT06787937

Conditions

Tobacco Products

Smoking Behavior

Cigarette Use

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

VLNC messages

Control message

Study Details

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.

Conditions

Tobacco Products

Smoking Behavior

Cigarette Use

Study ID

NCT06787937

Start date

Sep 11, 2025

Status verified date

Oct, 2025

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Enrollment

1230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: VLNC with message campaign

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.

other: VLNC only

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.

Interventions

VLNC messages

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.

Control message

Participants will be exposed to control messages, such as advertisements for bottled water, during their weekly visits.

Primary outcome measure

  • Cigarettes per day [ Time Frame: Week 4 of the trial (post randomization) ]

Central Contacts and Locations

Central contacts

Lyudmila Popova, Ph.D.

404-413-9338lpopova1@gsu.edu

Locations

Georgia State university

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Lyudmila Popova, Ph.D.

404-413-9338lpopova1@gsu.edu

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Nicholas Giordano, Ph.D.

404-727-7980nicholas.a.giordano@emory.edu

More Information

Sponsor

Georgia State University

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • smoking
  • health communication
  • very low nicotine cigarettes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgia State University on 2025-10-29.