Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to Quit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Current use of smoking cessation medication.
Provide a CO breath test reading less than 10 ppm at Intake.
Trial design
Treatments tested in this trial
- HRP Sampling period
- NPL Sampling period
Treatment groups
472 Participants
are divided into 2 treatment groupsSponsors and collaborators
Abramson Cancer Center at Penn Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov