Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated t… (NCT07199517) | Clinical Trial Compass
RecruitingNot Applicable
Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to Quit
United States472 participantsStarted 2026-01-12
Plain-language summary
This study aims to investigate harm-reduction sampling in a choice format versus medicinal nicotine sampling on smoking behavior, identify mechanisms of sampling's effects, and explore moderators of these effects among a national sample of people unmotivated to quit smoking. Participants will be randomized 2:1 to choose one of two harm-reduction products (ECIG, ONP) versus a medicinal nicotine control condition (nicotine patch + lozenge, NPL), receive a 4-week starter product regimen, and then be followed for 6 months to assess use behavior.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Able to communicate fluently in English (i.e., speaking, writing, and reading)
✓. Male and female smokers who are \> 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months.
✓. Have a carbon monoxide (CO) greater than or equal to 10 ppm
✓. Not using any forms of nicotine regularly other than cigarettes.
✓. Not interested in quitting smoking in the next 30 days.
✓. Capable of giving written informed consent, including compliance with the requirements and restrictions listed in the combined consent and HIPAA form
Exclusion criteria
✕. Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, IQOS, ONPS, etc.).
✕. Current or impending (during the study period) enrollment or plans to enroll in a smoking cessation program.
✕. Provide a CO breath test reading less than 10 ppm at Intake.
✕. History of substance abuse (other than nicotine dependence) in the past 12 months.
✕. Current alcohol consumption that exceeds 20 standard drinks/week.
✕. Current use of recreational drugs (other than nicotine and cannabis)
✕. Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period.