Communicating About Nicotine Reduction in Cigarettes

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Georgia State University
Study ID
NCT06787937
Status
Recruiting
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Conditions

  • Cigarette Use
  • Smoking Behavior
  • Tobacco Products

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 11, 2025
Status verified
Oct 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
1,230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Nicholas Giordano, Ph.D.
[email protected]
404-727-7980
Georgia State universityAtlantaGeorgia30303
Lyudmila Popova, Ph.D.
[email protected]
404-413-9338

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By research site
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