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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
21mg nicotine patch daily; maximum usage 9 weeks
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks
4mg Nicorette mint lozenge; as needed maximum usage 9 weeks
BIDI e-cigarette (flavors - Classic, Arctic, and Solar); as needed for maximum of 5 weeks
4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 5 weeks
Rose Research Center
Charlotte, North Carolina, United States
Rose Research Center
Raleigh, North Carolina, United States
Change in smoke exposure for NRT non-responders
Change in expired air CO at week 10 compared to baseline
Time frame: After 10 weeks
Smoking abstinence rates for NRT non-responders
Complete smoking abstinence defined by a self-report of no cigarette smoking (not even a puff).
Time frame: Week 7 - Week 10
Smoking abstinence rates for NRT non-responders
Complete smoking abstinence defined by expired air CO\<6 ppm.
Time frame: Week 7 - Week 10
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