Actively Recruiting
Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to Quit
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-05-04
472
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
Sponsors
A
Abramson Cancer Center at Penn Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to Quit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to communicate fluently in English (speaking, writing, and reading)
- Male and female smokers aged over 21 years
- Smoke at least 5 cigarettes (menthol or non-menthol) per day for at least the last 6 months
- Have a carbon monoxide (CO) level greater than or equal to 10 ppm
- Not using any nicotine products regularly other than cigarettes
- Not interested in quitting smoking in the next 30 days
- Capable of giving written informed consent and complying with study requirements
You will not qualify if you...
- Regular use of nicotine products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigarettes, IQOS, oral nicotine pouches)
- Current or planned enrollment in a smoking cessation program during the study
- Current use of smoking cessation medication
- Carbon monoxide (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 exceeding 20 standard drinks per week
- Current use of recreational drugs other than nicotine and cannabis
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Serious or unstable medical conditions within the past year (e.g., cancer, uncontrolled hypertension, cardiovascular events)
- Lifetime history of schizophrenia or psychosis
- Participation in another research program that could affect safety or study data
- Any medical condition, illness, adverse event, or medication that could compromise safety or study performance
- Significant non-compliance with protocol or study design as determined by the Principal Investigator
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
J
Janet Audrain-McGovern, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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