NCT06554873

Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Rose Research Center, LLC · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Smoking Cessation
• Harm Reduction

Interventions

Type	Name	Description
DRUG	Nicoderm	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.
DRUG	Nicorette 4Mg Chewing Gum	4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 24 weeks.
DRUG	Nicorette Lozenge Product	4mg Nicorette mint lozenge; as needed maximum usage 24 weeks.
OTHER	NJOY e-cigarette	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.
OTHER	on!	4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 24 weeks.

Timeline

• Start date: 2024-08-29
• Primary completion: 2025-12-09
• Completion: 2025-12-09
• First posted: 2024-08-15
• Last updated: 2026-02-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study