Messaging about lower-nicotine cigarettes and related policies.
Communicating About Nicotine and Differential Risks of Tobacco Products in Priority Populations
This study will test whether giving adult smokers very low-nicotine cigarettes together with messages about reduced nicotine and policy changes helps them smoke less than giving the cigarettes without those messages.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1230 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Georgia State University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06787937 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label, two-site study comparing two groups of adult smokers who use very low nicotine cigarettes (VLNCs): one group receives VLNCs plus a campaign of messages about reduced nicotine and policy, and the other receives VLNCs with neutral, non-tobacco messages. Participants include smokers with past-month serious psychological distress (SPD), smokers with low socioeconomic status (SES), and smokers in neither category. Messaging will be delivered via cigarette-pack inserts, print ads, and videos shown at weekly visits, and all participants will attend a 1-week baseline followed by a 4-week intervention period with weekly surveys, breath CO samples, and VLNC supply. Outcomes focus on changes in cigarette use and attitudes toward VLNCs and nicotine policy.
Who should consider this trial
Good fit: Adults aged 21 or older who are regular smokers (≥100 lifetime cigarettes, smoking on at least 27 of the last 30 days, and CO ≥6 ppm), can read and speak English, are available for the study period, and are willing to try research cigarettes.
Not a fit: People who are pregnant or breastfeeding, unwilling to use research cigarettes, not regular smokers, or who cannot attend weekly in-person visits are unlikely to benefit from this specific study.
Why it matters
Potential benefit: If successful, combining messages with very low nicotine cigarettes could help smokers reduce the number of cigarettes they smoke and shift attitudes that support nicotine-reduction policies.
How similar studies have performed: Prior clinical work has shown that very low nicotine cigarettes can reduce smoking and dependence, but combining VLNC use with a targeted messaging campaign about nicotine reduction and policy is a relatively new approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia and 1 other locations
- Georgia State university — Atlanta, Georgia, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: Lyudmila Popova, Ph.D.
- Email: lpopova1@gsu.edu
- Phone: 404-413-9338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.