Vape Use Among Younger & Older Smokers

NCT07214168 | Recruiting

• 2 other identifiers: UPCC 13025Protocol # 858558
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to recruit 100 current cigarette smokers (50 young adults ages 21-34; 50 older adults ages 35-65) who have tried vaping or are currently vaping (dual users). The study will examine the trajectories in tobacco use (cigarettes and/or ENDS), including the nuanced differences in ENDS use (i.e., detailed device characteristics, user preferences, patterns of use), according to smoker age group.

Conditions

Smoking Cigarette; Smoking Behaviors; Vaping; Vaping Behaviors

Keywords

Vaping; Cigarette Smoking

Outcome Measures

Primary Outcomes (6)

• Digital Diary (Mobile App)

  Participants will be asked to create an account for a mobile application that will serve as a digital diary to track any potential changes in tobacco product use, specifically ENDS and cigarette use, frequency of use for both products, and reasons for this change. The mobile app will ask the participant on a weekly basis whether there was any change to smoking and vaping habits from the past week. Collection of weekly data will provide granularity and a better understanding of the nuanced differences in ENDS use according to age group over the course of the 12-month enrollment period.

  1 time per week for 5 months (Between Sessions)

• ENDS Use (Open Ended Response)

  To identify the factors that impact ENDS use, participants will be asked to provide personal reasons to start vaping or try new ENDS products, continue vaping, or quit vaping.

  5-6 months (at three time points)

• ENDS Risk Beliefs

  Participants will be asked questions adapted to ENDS use about their product perceptions, including measures of risk beliefs.

  5-6 months (at three time points)

• ENDS Perceived Health Risks

  Participants will be asked questions adapted to ENDS use about their product perceptions, including measures of perceived health risks.

  baseline

• ENDS Attitudes & Intentions

  Participants will be asked to report on attitudes and intentions towards using ENDS, and social norms (the number of friends/family who smoke and/or vape and what friends/family behaviors/beliefs are on products; what the participants' beliefs about others approval of products are).

  5-6 months (at three time points)

• ENDS Personal Experience

  Participants will be asked about personal experiences with ENDS use (physical sensation, experienced effects, ability to satisfy cravings, product problems, convenience of use, cost, regulation).

  5-6 months (at three time points)

Secondary Outcomes (7)

• Subjective Cigarette Ratings

  5-6 months (at three time points)

• Puff Duration (via smoking topography)

  5-6 months (at three time points)

• Nicotine Metabolites (Urine Sample)

  5-6 months (at three time points)

• Carbon Monoxide (CO) assessment

  5-6 months (at three time points)

• Craving

  5-6 months (at three time points)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Male and female cigarette smokers who are between 21 and 65 years of age. * Self-report having vaped at least once in the last six months (i.e. tried vaping) or are currently vaping. * Self-report smoking at least 5 filtered cigarettes per week for at least the last 12 months. * Able to attend 3 in-person visits in Philadelphia, PA

You may qualify if:

• Male and female cigarette smokers who are between 21 and 65 years of age.
• Self-report having vaped at least once in the last six months (i.e. tried vaping) or are currently vaping.
• Self-report smoking at least 5 filtered cigarettes per week for at least the last 12 months.
• Not currently undergoing smoking cessation treatment or planning to quit prior to enrollment in the study.
• Able to attend 3 in-person visits in the Philadelphia area.
• Willing to smoke a cigarette in a ventilated smoking laboratory at each in-person visit.
• Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
• Able to communicate fluently in English (i.e., speaking, writing, and reading).

You may not qualify if:

• Smoking Behavior
• Use of any nicotine containing products other than cigarettes or ENDS. Participants reporting isolated use of other nicotine containing products less than 5 times per month are eligible to participate.
• Alcohol and Drug Use
• History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Attendance at alcoholics anonymous or narcotics anonymous meetings will not be considered medical treatment for the purposes of this protocol.
• Current alcohol consumption that exceeds 25 standard drinks/week.
• Medical
• Women, including all individuals assigned as female at birth, who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period.
• Any psychiatric disorder that (as determined by the Principal Investigator) would interfere with study participation
• Serious or unstable medical condition. Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator.
• Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact participant safety, study data, and/or the study design as determined by the Principal Investigator.
• Any circumstance, medical condition, illness, disorder, adverse event (AE), or medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator. Participants may be withdrawn for any of the aforementioned reasons at any point throughout the study.
• Significant non-compliance with the protocol and/or study design as determined by the Principal Investigator. Participants may be withdrawn at any point throughout the study.

Sponsors & Collaborators

• Food and Drug Administration (FDA): collaborator
• Abramson Cancer Center at Penn Medicine: lead
• The Center for Coordination of Analytics, Science, Enhancement and Logistics (CASEL): collaborator

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples will be collected to analyze nicotine metabolites in the body, such as cotinine.

MeSH Terms

Conditions

Cigarette Smoking; Smoking; Vaping

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Study Officials

• Angela Aherrera, DrPH, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Andrew Strasser, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Goren, MRA

CONTACT

215-746-3602; vsoup@pennmedicine.upenn.edu

Catherine Kreider, MSW

CONTACT

215-746-2631; cathk@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 9, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)