~827 spots leftby Jan 2029

VLNC Messages for Smoking

Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Georgia State University
No Placebo Group

Trial Summary

What is the purpose of 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.

Research Team

Eligibility Criteria

This trial is for adult smokers, including those with recent serious psychological distress or low socioeconomic status. Participants must be willing to attend weekly study visits and complete daily surveys via text message.

Inclusion Criteria

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)
I am 21 years old or older.
Can speak, read, and write in English
See 2 more

Exclusion Criteria

Pregnancy or lactation
Member of the same household as a study subject
I am not willing to smoke research cigarettes.

Treatment Details

Interventions

  • Control message (Behavioral Intervention)
  • VLNC messages (Behavioral Intervention)
Trial OverviewThe study tests if a messaging campaign about reduced nicotine cigarettes affects smoking behavior when combined with using very low nicotine cigarettes (VLNCs). It compares the effects of VLNCs with messages versus VLNCs alone.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: VLNC with message campaignExperimental Treatment1 Intervention
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.
Group II: VLNC onlyExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials
71
Recruited
33,600+

Dr. Jian-Dong Li

Georgia State University

Chief Executive Officer since 2011

PhD in Biomedical Sciences from University of California, San Francisco; MD from Qingdao University School of Medicine

Dr. Steve Simonson

Georgia State University

Chief Medical Officer since 2014

MD from Medical College of Wisconsin; Master's in Health Sciences from Duke University School of Medicine

University of South Carolina

Collaborator

Trials
233
Recruited
122,000+
Hippokratis Kiaris profile image

Hippokratis Kiaris

University of South Carolina

Chief Executive Officer since 2021

PhD in Molecular Biology

Marjorie Jenkins profile image

Marjorie Jenkins

University of South Carolina

Chief Medical Officer since 2023

MD

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+
Dr. R. Donald Harvey profile image

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter profile image

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy profile image

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli profile image

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School