NCT06088862

Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT

A Randomized Study to Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With Nicotine Replacement Therapy (NRT)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Rose Research Center, LLC · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will determine whether a range of products along the reduced-risk continuum can reduce smoke exposure for individuals who fail to quit smoking using current medically approved nicotine replacement therapy (NRT) products. The strategy will be to offer 325 smokers four weeks of NRT of their choice (gum, lozenge, or nicotine patch) and assess them for quit-smoking status at the end of the period. Seven-day point abstinence will be used to determine responder status at the end of the four-week period (CO of \<6 ppm at both CO collection points during that seven-day period and self-report of no smoking during that seven-day period). Those who have not quit, and who therefore have a very low chance of later success (a consistent finding in prior studies and to be verified in the proposed study), will be randomly assigned to either receive a potential "rescue" product (nicotine pouch or ENDS (electronic nicotine delivery system), or remain on NRT (control group).

Conditions

• Smoking Cessation
• Harm Reduction

Interventions

Type	Name	Description
DRUG	Nicoderm	21mg nicotine patch daily; maximum usage 9 weeks
DRUG	Nicorette 4Mg Chewing Gum	4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks
DRUG	Nicorette Lozenge Product	4mg Nicorette mint lozenge; as needed maximum usage 9 weeks
OTHER	BIDI e-cigarette	BIDI e-cigarette (flavors - Classic, Arctic, and Solar); as needed for maximum of 5 weeks
OTHER	on!	4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 5 weeks

Timeline

• Start date: 2023-12-27
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2023-10-18
• Last updated: 2025-03-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study