drugset / Trial / NCT03272685
Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace
Phase 3
Completed
799 enrolled
University of Minnesota
Brown University · collabDuke University · collabUniversity of California, San Francisco · collabUniversity of Pennsylvania · collabWake Forest University · collab
RandomizedParallel-groupOpen-labelBasic science
Summary
This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked and cigarette-free days in an experimental marketplace that contains VLNC cigarettes versus normal nicotine content (NNC) cigarettes.
Timeline
- Start
- 2018-06-01
- Primary completion
- 2022-09-30
- Completion
- 2023-01-10
Outcome
Met primary endpoint
paper those in the 0.4 mg vs. 15.8 mg nicotine cigarette condition experienced significantly lower cigarettes per day at the end of intervention PMID 38911348 ↗
paper greater smoke-free days during intervention (mean [SD], 18.59 [27.97] vs. 5.06 [13.77], adjusted rate ratio, 4.25 [95% CI, 2.58-6.98], P < 0.0001) PMID 38911348 ↗
Publications
- Benowitz NL, Hu J, Luo X, McClernon FJ, Tidey J, Strasser AA, Colby S, Donny EC, Hatsukami DK. Titration of nicotine intake in smokers switching to reduced nicotine content cigarettes with access to alternative nicotine systems: Secondary analysis of a randomized clinical trial. Addiction. 2026 Jul;121(7):1899-1906. doi: 10.1111/add.70385. Epub 2026 Mar 19.
- Said RJ, Carroll DM, Luo X, Hu J, Cao Q, Tessier KM, Bittencourt L, Hatsukami DK; Center for Evaluation of Nicotine in Cigarettes (CENIC). Secondary analysis of a randomized clinical trial of very low nicotine cigarettes: Outcomes across social and demographic groups. Prev Med. 2025 Dec;201:108362. doi: 10.1016/j.ypmed.2025.108362. Epub 2025 Jul 21.
- Hatsukami DK, Jensen JA, Carroll DM, Luo X, Strayer LG, Cao Q, Hecht SS, Murphy SE, Carmella SG, Denlinger-Apte RL, Colby S, Strasser AA, McClernon FJ, Tidey J, Benowitz NL, Donny EC. Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial. Lancet Reg Health Am. 2024 Jun 3;35:100796. doi: 10.1016/j.lana.2024.100796. eCollection 2024 Jul.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Normal Nicotine Content Cigarettes | Unknown | 15.8 unknown | — |
| Subject | Very Low Nicotine Content Cigarettes | Unknown | 0.4 unknown | — |