Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to Quit
Recruiting now · Not applicable
Conditions studied: Cigarette Smoking, Tobacco Use, Cigarette Smoking Behavior
In brief
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.
Key facts
- Study ID
- NCT07199517
- Run by
- Abramson Cancer Center at Penn Medicine
- People needed
- 472
- Starts
- 2026-01-12
- Expected to finish
- 2030-07-31
- Last updated by the study team
- 2026-06-11
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Smoking Behavior
- 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.
- Alcohol and Drug
- 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)
- Medical
- Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period.
- Serious or unstable disease within the past year (e.g. cancer, uncontrolled hypertension, cardiovascular event).
- Psychiatric
- Lifetime history of schizophrenia or psychosis.
- General Exclusion
- Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator.
- Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/o. Subjects may be deemed ineligible at any point throughout the study.
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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