Phase 3 N=438 Randomized Basic Science

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

Tobacco Smoking · Nicotine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT03272685 ↗

Enrolled (actual)

438

Serious AEs

3.0%

Results posted

Aug 2024

Primary outcome: Primary: Cigarettes Per Day (CPD) — 7.05; 12.95 cigarettes per day

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Very Low Nicotine Content Cigarettes (Drug); Normal Nicotine Content Cigarettes (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Sep 2022

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03272685). 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.