To determine whether smokers who initially respond (within 2 weeks) to nicotine products (including nicotine replacement therapy, e-cigarettes, nicotine pouches) by reducing their smoking by ≥50% can be successfully maintained on use of these noncombustible nicotine alternatives to cigarettes for 6 months, and whether this results in sustained smoking reduction/abstinence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Depending on responder status and group assignment the maximum amount of time nicotine patches will be used is 24 weeks. The final four weeks of nicotine patch treatment will comprise 2 weeks of 14 mg patches and two weeks of 7 mg patches.
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 24 weeks.
4mg Nicorette mint lozenge; as needed maximum usage 24 weeks.
Rose Research Center
Charlotte, North Carolina, United States
Rose Research Center
Raleigh, North Carolina, United States
Smoking abstinence - CO
To determine whether maintained use of nicotine products can help sustain smoking abstinence rates for early responders. An expired air CO reading of ≤ 5 ppm at 24 weeks.
Time frame: Week 12 and Week 24
Smoking abstinence - Self report of no smoking
Percent smoking abstinence at 12 weeks and 24 weeks, defined on an intent-to-treat basis as a self-report of no-smoking for the prior 7 days
Time frame: Week 12 and Week 24
Reduction in Expired Air CO
Percent of participants achieving a 50% reduction in expired air CO at 12 weeks and 24 weeks relative to baseline.
Time frame: Week 12 and Week 24
Usage of Nicotine Products
Self-reported usage of nicotine products.
Time frame: Week 1 through Week 24, Week 36
Saliva Cotinine Concentrations
Saliva cotinine concentrations reflective of nicotine product usage in smoking-abstinent individuals.
Time frame: Week 12, Week 24, Week 36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Each NJOY Classic Tobacco and Menthol pod is pre-filled with 1.9 mL of e-liquid with 5% nicotine (by weight); as needed maximum usage 24 weeks.
4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 24 weeks.