Communicating About Nicotine Reduction in Cigarettes

NCT06787937 | Recruiting DMC

• 2 other identifiers: H25318R01CA239308
• Study Type: interventional
• Target: 1,230
• Locations: 1 country
• Sites: 2

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

Keywords

smoking; health communication; very low nicotine cigarettes

Outcome Measures

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.

  Week 4 of the trial (post randomization)

Secondary Outcomes (7)

• Use of other tobacco products

  Week 4 of the trial (post randomization)

• Use of cessation medications

  Week 4 of the trial (post randomization)

• Forgoing cigarettes

  Through study completion, up to 4 weeks

• Making a quit attempt

  Through study completion, up to 4 weeks

• Perceived risk of smoking VLNCs

  Week 4 of the trial (post randomization)

Study Arms (2)

VLNC with message campaign

EXPERIMENTAL

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.

Behavioral: VLNC messages

VLNC only

OTHER

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.

Behavioral: Control message

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.

VLNC with message campaign

Control message BEHAVIORAL

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

VLNC only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Georgia State University: lead
• Emory University: collaborator
• University of South Carolina: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Georgia State university

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Related Publications (1)

• Pei D, Juris A, Nkansah P, Thrasher JF, Giordano NA, Henderson KC, Spears CA, Ashley DL, Mallory VC, Adeniji FP, Foster JD, Ni W, Kodriati N, Ogunnaike A, Pechacek TF, Kirpich A, Popova L. Nicotine Intervention and Communication for Empowering Reduction (NICER): study protocol for a randomized controlled trial among priority populations of people who smoke. Trials. 2025 Nov 17;26(1):514. doi: 10.1186/s13063-025-09216-8.

  PMID: 41250122 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Lyudmila Popova, Ph.D.

CONTACT

404-413-9338; lpopova1@gsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 22, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)