NCT07199517 · Abramson Cancer Center at Penn Medicine
Catalyzing Cigarette Smoking Cessation Through Harm Reduction Sampling Among People Unmotivated to Quit
What this study 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.
View original scientific description
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.
Interventions
OTHER
HRP Sampling period
During a 28-day sampling period, participants randomized to HRP are instructed to try their selected HRP (ECIGS or ONPs) and will complete daily e-diaries of cigarette smoking behavior and product uptake.
OTHER
NPL Sampling period
During a 28-day sampling period, participants randomized to NPL are instructed to try nicotine patches and nicotine lozenges and will complete daily e-diaries of cigarette smoking behavior and product uptake.
Primary outcome measures
Smoking abstinence
Time frame: 29 weeks
Seven-day point prevalence smoking abstinence (CO \< 5) will be measured at the 3-month (secondary endpoint) and 6-month follow-up (primary endpoint) via the valid and reliable TLFB procedure and biochemically verified through a CO \< 5 ppm.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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 1\. 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
- Philadelphia, Pennsylvania
Collaborators
National Cancer Institute (NCI), University of Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations