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
25 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
Researchers are studying harm-reduction sampling compared to medicinal nicotine sampling to understand their effects on smoking behavior among people who are not motivated to quit smoking soon. This study aims to explore how sampling influences smoking habits and the factors that may affect these results. It focuses on adults who smoke regularly but do not plan to quit in the next 30 days, with the goal of reducing smoking-related health risks by offering appealing alternatives to cigarettes. Participants will be randomly assigned in a 2:1 ratio to either choose between two harm-reduction products—e-cigarettes (ECIG) or oral nicotine pouches (ONP)—or to receive a medicinal nicotine control consisting of nicotine patches and lozenges (NPL). Those selecting harm-reduction products will try and rate ECIGs and ONPs during two virtual visits, while the control group will try the patch and lozenge in one virtual visit. Each participant will then receive a 4-week supply of their chosen or assigned product to use during the sampling period. During the 4-week sampling period, participants will complete daily electronic diaries about their cigarette smoking and product use. Researchers will follow them for six months to measure smoking abstinence confirmed by biochemical tests, with additional assessments at 3 months. Other outcomes include attempts to quit for 24 hours and reducing cigarette use by half. The study includes regular virtual visits, monitoring, and safety checks, with total involvement lasting about six months.
CONDITIONS
Brief 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
- Male and female smokers aged 21 years or older
- Self-report smoking at least 5 cigarettes daily for at least the last 6 months
- Carbon monoxide (CO) level of 10 ppm or higher
- Not regularly using any nicotine products 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, oral nicotine pouches)
- Current or planned enrollment in a smoking cessation program during the study
- Current use of smoking cessation medication
- CO breath test reading less than 10 ppm at intake
- History of substance abuse other than nicotine dependence in the past 12 months
- 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 disease within the past year (e.g., cancer, uncontrolled hypertension, cardiovascular event)
- Lifetime history of schizophrenia or psychosis
- Enrollment in another research program that might affect safety or study data
- Any medical condition or medication that could compromise safety or study performance
- Significant non-compliance with protocol or study design
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 virtual visits to try and rate harm reduction products or 1 virtual lab visit to try nicotine patch and lozenge
Duration - 28 days
Participants use a 4-week supply of their selected product (either harm reduction products such as e-cigarettes or oral nicotine pouches, or nicotine patch and lozenge) and complete daily e-diaries about cigarette smoking behavior and product use.
Daily e-diaries during the 4-week sampling period
Duration - Up to 29 weeks
Participants are followed up to assess smoking abstinence, reduction, and quit attempts.
Assessments at 3-month and 6-month follow-ups
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.
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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