Actively Recruiting
Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-03-12
200
Participants Needed
1
Research Sites
21 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 evaluating if e-cigarettes (ECIGS) or oral nicotine pouches (ONPS) are better substitutes for combustible cigarettes among 200 persistent cigarette smokers. This study aims to understand if smokers can switch to these noncombustible options, how factors influence switching, and whether one exposes users to fewer harmful chemicals. The research is sponsored by Abramson Cancer Center at Penn Medicine and will fill important gaps about harm reduction tools for smokers who do not quit. Participants will be randomly assigned to use either ECIGS or ONPS for six weeks, after a baseline period to measure their usual cigarette smoking rate. Those in the ECIGS group will receive an e-cigarette device with a choice of flavored nicotine pods, while those in the ONPS group will receive flavored nicotine pouches. Supplies will be provided in weekly amounts based on initial smoking behavior, and participants will be instructed to switch completely from cigarettes to their assigned product during the six-week period. Throughout the study, participants' cigarette consumption will be tracked daily, and biomarkers of exposure to harmful chemicals will be measured at baseline and after six weeks. Subjective rewards and the reinforcing value of ECIGS and ONPS compared to cigarettes will be assessed in laboratory visits after confirmed smoking abstinence. Follow-up will continue for six months to monitor smoking behavior. The study includes multiple evaluations such as carbon monoxide breath tests and lung function measurements to monitor changes and safety during participation.
CONDITIONS
Brief Title
Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers
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
- Self-report smoking at least 5 cigarettes per day for at least the last 6 months
- Have made 5 or more failed quit attempts with use of cessation medication at least once
- Carbon monoxide (CO) level greater than 10 ppm
- Not regularly using any nicotine products other than cigarettes
- Willing to switch to e-cigarettes or nicotine pouches for 6 weeks
- Plan to live locally for the study duration
- Capable of giving written informed consent including compliance with study requirements
You will not qualify if you...
- Regular use of nicotine products other than cigarettes more than 5 days in the past 30 days
- Current enrollment or plans to enroll 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) in the past 12 months
- Current alcohol use exceeding 20 standard drinks per week
- Current use of recreational drugs other than nicotine and cannabis
- Breath alcohol reading greater than .000 at intake
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Serious or unstable disease in the past year (e.g., cancer, heart disease)
- Lifetime history of schizophrenia or psychosis
- Participation in another research program that could impact safety or study data
- Any condition or medication compromising 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.
1 visit (in-person)
Duration - 7 days
Participants establish baseline smoking rate and undergo biochemical confirmation of smoking abstinence, including laboratory visits to assess nicotine product reward and reinforcing value.
2 visits (in-person laboratory visits on days 6 and 7)
Duration - 6 weeks
Participants switch from smoking combustible cigarettes to using either e-cigarettes or oral nicotine pouches for 6 weeks.
Weekly visits for up to 6 weeks
Duration - Approximately 5 months
Participants are followed for smoking behavior and biomarker assessments up to 6 months after treatment to evaluate long-term cigarette consumption and exposure changes.
1 visit at 6-month follow-up
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
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here