Phase 3
Completed N=438
Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace
Tobacco Smoking · Nicotine Dependence
Source: ClinicalTrials.gov NCT03272685 ↗
Enrolled (actual)
438
Serious AEs
3.0%
Results posted
Aug 2024
Primary outcomePrimary: Cigarettes Per Day (CPD) — 7.05; 12.95 cigarettes per day
◆ Published Evidence
Established
23citations · ~12 / year
Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial.
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.
Linked Publications (3)
-
Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial.
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Secondary analysis of a randomized clinical trial of very low nicotine cigarettes: Outcomes across social and demographic groups.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarettes Per Day (CPD) |
7.05; 12.95 | — |
| PRIMARY Number of Smoke-free Days |
18.6; 5.1 | — |
| SECONDARY Percent Change in 2-cyanoethyl-mercapturic Acid (CEMA) |
-34; 8 | — |
| SECONDARY Study Cigarettes Per Day |
5.33; 12.42 | — |
| SECONDARY Seven Day Point-prevalence CO-verified Abstinence |
41; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female;
- 18/21 (legal age to purchase tobacco at site);
- Biochemically confirmed smoker.
Exclusion Criteria
- Unstable health condition;
- Unstable medications;
- Pregnant or nursing.
Data sourced from ClinicalTrials.gov (NCT03272685) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.