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Smoking CigaretteENDSNCT07214168

Vape Use Among Younger & Older Smokers

An observational study of Smoking Cigarette and Smoking Behaviors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Smoking Cigarette, Smoking Behaviors, Vaping
How many people
62 participants
Where
1 siteUnited States
Study dates
5 Sep 2025to 28 Aug 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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).

Who cannot join

  • 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
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  • 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.
  • General Exclusion
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Interdisciplinary Research on Nicotine Addiction

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Factors That Affect Differential Switching and Patterns of ENDS Use Among Younger and Older Smokers: A Mixed Methods Approach

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.

Keywords
Vaping, Cigarette Smoking
Medical subject headings
Cigarette Smoking, Smoking, Vaping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 time per week for 5 months (Between Sessions)

  2. 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.

    Measured: 5-6 months (at three time points)

  3. ENDS Risk Beliefs

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

    Measured: 5-6 months (at three time points)

  4. ENDS Perceived Health Risks

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

    Measured: baseline

  5. 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).

    Measured: 5-6 months (at three time points)

  6. 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).

    Measured: 5-6 months (at three time points)

Secondary outcomes (7)

  1. Subjective Cigarette Ratings

    Participants will provide subjective ratings of all cigarettes smoked during laboratory sessions using a 14-item, 100 mm visual analog scale (VAS) of cigarette characteristics (e.g., taste) used by the tobacco industry and our laboratory. Anchors are item-specific (e.g., taste: 0 = "very bad," 100 = "very good"), with lower scores indicating less favorable ratings. Subjective cigarette ratings will be assessed after each cigarette smoked in the laboratory across all sessions. The participant will also complete a modified version of the same form at each session for ENDS use. Participant ENDS subjective ratings will be collected after each vaping period in the laboratory (if applicable).

    Measured: 5-6 months (at three time points)

  2. Puff Duration (via smoking topography)

    Both smoking and vaping (if applicable) behaviors will be assessed using video-scored measures of topography (i.e., puffing behavior), which includes the number of puffs taken, and total inter-puff interval. A digital timestamp feature in opensource video editing software will be used to estimate start and end times for individual puffs based on various physical cues (i.e., inhaling, glowing cigarette tips or ENDS device).

    Measured: 5-6 months (at three time points)

  3. Nicotine Metabolites (Urine Sample)

    Spot urine samples will be collected using acid washed collection cups. Urine will be used to measure metals, aldehyde metabolites, cotinine, creatinine. Biospecimens will be frozen at < -80°C in freezers operated under a strict quality control system. The time in which each participant last vaped and when the biospecimen samples were collected will be recorded.

    Measured: 5-6 months (at three time points)

  4. Carbon Monoxide (CO) assessment

    CO levels will be measured using a breath CO monitor to assess tobacco exposure.The CO monitor is a handheld device that uses a disposable mouthpiece, reports CO in parts per million (ppm), and takes about 3 minutes to administer. Participants will smoke a cigarette of choice in the laboratory, and CO measurements will be collected to assess the difference before and after the cigarette smoked, or CO boost, to measure smoke exposure from a single cigarette. Collection of these secondary measures will allow the team to evaluate differences in tobacco and nicotine exposure between age groups, which may be impacted by participants' cigarette and ENDS product of choice and the potentially differing patterns of use between products.

    Measured: 5-6 months (at three time points)

  5. Craving

    Participants will report cigarette craving and nicotine withdrawal symptoms at the onset of each visit. Craving will be assessed using a summary score and two factor subscales (i.e., desire to smoke and craving due to anticipation of negative affect relief) from the 32-item Questionnaire on Smoking Urges (QSU).

    Measured: 5-6 months (at three time points)

  6. Withdrawal

    Withdrawal will be assessed using a summary score from the 20-item (21 items at Session 1 [D0]) revised version of the Withdrawal Symptom Checklist (WSC-W [1-week frame of reference]).

    Measured: 5-6 months (at three time points)

  7. Attitude & Intention to Use Product

    Participants' attitudes and intentions toward their cigarette packs will be assessed, similar to the lab's previous work on cigarette smoking that applied the Reasoned Action Approach. Likert-type semantic differential scales will be used (likely to use/not use, enjoyable/non enjoyable, harmful/not harmful). Participants will complete the Attitudes and Intentions Questionnaire across all sessions after smoking each lab cigarette. The participant will also complete a modified version of the same form at each session for ENDS use. Participant ENDS Attitudes \& Intentions will be collected after each vaping period in the laboratory (if applicable).

    Measured: 5-6 months (at three time points)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2025
  2. Study start5 Sep 2025
  3. Primary completion28 Aug 2026
  4. Study completion28 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07214168
Sponsor's protocol ID
UPCC 13025
Other IDs
Protocol # 858558
Acronym
ENDS
Status last verified
Sep 2026
First submitted
18 Sep 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Smoking Cigarette and Smoking Behaviors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Digital Diary (Mobile App) (time frame: 1 time per week for 5 months (Between Sessions)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07214168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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