Status:
NOT_YET_RECRUITING
PUQS Sampling Study
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
University of Pennsylvania
Conditions:
Cigarette Smoking
Tobacco Use
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Catalyzing smoking behavior change among people unready or unmotivated to quit smoking (PUQS) has the potential to disrupt decades of smoking and toxicant exposure, drastically reducing smoking-attrib...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT07199517
Start Date
December 1 2025
End Date
July 1 2030
Last Update
September 30 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104