SmokingYLPNCT03699865
Young Adults and Low Nicotine Cigarettes
A study testing Nicotine content in people with Smoking, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The purpose of this study is to look at the effects of investigational low nicotine cigarettes on young adult smokers. The investigators are interested in how using these products affects young adults' perceptions and smoking behaviors. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Nicotine content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Oct 2024
- Phase
- Interventional
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Study participants will be 100 male and female young adult smokers who:
- Are aged 18-25
- Report smoking ≥ 100 lifetime cigarettes
- Report smoking at least 1 non-menthol, filtered cigarette per day
Who cannot join
- We will exclude those who:
- Plan to quit smoking in the next month
- Smoke menthol cigarettes > 80% of the time
- Report consuming ≥ 25 alcohol-containing drinks per week
- Report a history or current psychiatric diagnosis or severe medical condition,
- Are color-blind or have another visual impairment (e.g., partial blindness, uncorrected cataract)
Show all 11Show fewer
- Are pregnant and/or lactating
- Additional, general reasons for exclusion include:
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at any point throughout the study.
- 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 and/or Study Physician.
- 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 and/or Study Physician. 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to look at the effects of investigational low nicotine cigarettes on young adult smokers. The investigators are interested in how using these products affects young adults' perceptions and smoking behaviors. This research may help inform the Food and Drug Administration (FDA) how best to regulate tobacco products in the future with the goal of improving public health.
Read the detailed description
Investigators will recruit 100 young adult cigarette smokers to a 40-day, laboratory-based protocol. You will provide and smoke your preferred brand cigarettes for an initial 5-day baseline period, then receive your own brand free-of-charge for an additional 5-day period, and then will receive free, investigational low nicotine cigarettes for the remaining study duration (i.e., 30 days total). Low nicotine cigarettes will be provided in three varieties; each variety will be used for a 10-day period, in counterbalanced order. Primary outcomes will include smoking behaviors (daily cigarette consumption and total puff volume), harm perceptions (i.e., beliefs about product safety), and tobacco exposure (i.e., carbon monoxide [CO]). You will complete in-person visits at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) every 5 days, for a total of nine in-person visits.
- Conditions
- Smoking
- Being tested
- Nicotine content
- Keywords
- low nicotine, smoking behaviors, risk perceptions
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine contentOther
Study-supplied cigarettes will contain either intermediate or very low nicotine content
| Study group | Role | What they receive |
|---|---|---|
| Purple | Experimental | Participants will receive cigarettes with intermediate or very low nicotine content in purple packaging Receives: Other: Nicotine content |
| White | Experimental | Participants will receive cigarettes with intermediate or very low nicotine content in white packaging Receives: Other: Nicotine content |
| Black | Experimental | Participants will receive cigarettes with intermediate or very low nicotine content in black packaging Receives: Other: Nicotine content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily cigarette consumption
Daily cigarette consumption will be assessed primarily by participant self-report and secondarily through collection of spent filters for all cigarettes smoked during the 35-day study period, and will be averaged across baseline and pack color periods.
Measured: Days 0 through 40
Secondary outcomes (3)
Total puff volume
Total puff volume (total smoke inhaled per cigarette) will be collected twice during laboratory visits using a handheld, portable, electronic topography device. Assessments will be averaged across study periods.
Measured: Days 0, 5, 10, 15, 20, 25, 30, 35, and 40
Risk perceptions
Perceptions of risks of using study cigarettes will be assessed at the end of own brand and pack color periods using individual items and a summary score from an 8-item, 5-point Likert scale (1 = "definitely untrue", 5 = "definitely true") stating: "Compared to your own cigarettes, the cigarettes you are currently smoking…": a) "are lower in nicotine", b) "are lower in tar", c) "are less addictive", d) "are less likely to cause cancer", e) "have fewer chemicals", f) "are healthier", g) "make smoking safer", h) "help people quit smoking."
Measured: Days 10, 20, 30, and 40
Harm exposure
Harm exposure will be approximated by changes in expired air carbon monoxide (CO), a commonly used biochemical measure of tobacco smoke exposure that is sensitive to changes in puffing behavior. We will assess CO at the onset of each visit to represent daily exposure, as well as before and after each cigarette smoked during laboratory visits. The change in CO values resulting from smoking a cigarette will estimates smoke exposure due to smoking an individual cigarette.
Measured: Days 0, 5, 10, 15, 20, 25, 30, 35, and 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study startOct 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized, single-blind, 2 x 4 mixed factorial design laboratory-based study manipulating: (1) cigarette pack color (4-level within-subjects factor: own brand vs. white vs. purple vs. black color), and (2) nicotine content (2-level between-subjects factor: moderate vs. very low nicotine content). All participants will provide and smoke their preferred brand for an initial 5-day baseline period, receiver their own brand free-of-charge for 5-days, and then will be randomly assigned to smoke either intermediate or very low LNC cigarettes for the study duration. We will supply participants with LNC cigarettes in three pack colors; each color will be used for a 10-day period, in counter-balanced order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Melissa Mercincavage, Abramson Cancer Center at Penn Medicine
- Investigators
- Melissa Mercincavage, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699865
- Sponsor's protocol ID
- UPCC 10021
- Other IDs
- 1K07CA218366-01A1, 829101
- Acronym
- YLP
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2018
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adults and Low Nicotine Cigarettes
- ClinicalTrials.gov ID
- NCT03699865
- Acronym / sponsor ID
- YLP / UPCC 10021
- Conditions
- Smoking
- Keywords
- low nicotine, smoking behaviors, risk perceptions
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at the effects of investigational low nicotine cigarettes on young adult smokers. The investigators are interested in how using these products affects young adults' perceptions and smoking behaviors. This research may help inform the Food and Drug Administration (FDA) how best to regulate tobacco products in the future with the goal of improving public health.
Detailed description
Investigators will recruit 100 young adult cigarette smokers to a 40-day, laboratory-based protocol. You will provide and smoke your preferred brand cigarettes for an initial 5-day baseline period, then receive your own brand free-of-charge for an additional 5-day period, and then will receive free, investigational low nicotine cigarettes for the remaining study duration (i.e., 30 days total). Low nicotine cigarettes will be provided in three varieties; each variety will be used for a 10-day period, in counterbalanced order. Primary outcomes will include smoking behaviors (daily cigarette consumption and total puff volume), harm perceptions (i.e., beliefs about product safety), and tobacco exposure (i.e., carbon monoxide [CO]). You will complete in-person visits at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) every 5 days, for a total of nine in-person visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized, single-blind, 2 x 4 mixed factorial design laboratory-based study manipulating: (1) cigarette pack color (4-level within-subjects factor: own brand vs. white vs. purple vs. black color), and (2) nicotine content (2-level between-subjects factor: moderate vs. very low nicotine content). All participants will provide and smoke their preferred brand for an initial 5-day baseline period, receiver their own brand free-of-charge for 5-days, and then will be randomly assigned to smoke either intermediate or very low LNC cigarettes for the study duration. We will supply participants with LNC cigarettes in three pack colors; each color will be used for a 10-day period, in counter-balanced order.
| Arm | Type | Receives |
|---|---|---|
| Purple | Experimental | Other: Nicotine contentParticipants will receive cigarettes with intermediate or very low nicotine content in purple packaging |
| White | Experimental | Other: Nicotine contentParticipants will receive cigarettes with intermediate or very low nicotine content in white packaging |
| Black | Experimental | Other: Nicotine contentParticipants will receive cigarettes with intermediate or very low nicotine content in black packaging |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Study participants will be 100 male and female young adult smokers who:
Key exclusion criteria (11 listed)
- We will exclude those who:
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at any point throughout the study.
- 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 and/or Study Physician.
- 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 and/or Study Physician. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine contentStudy-supplied cigarettes will contain either intermediate or very low nicotine content | Other | Black, Purple, White |
Primary outcome
Daily cigarette consumption
Time frame: Days 0 through 40
Daily cigarette consumption will be assessed primarily by participant self-report and secondarily through collection of spent filters for all cigarettes smoked during the 35-day study period, and will be averaged across baseline and pack color periods.
3 secondary outcomes
Total puff volume
Time frame: Days 0, 5, 10, 15, 20, 25, 30, 35, and 40
Risk perceptions
Time frame: Days 10, 20, 30, and 40
Harm exposure
Time frame: Days 0, 5, 10, 15, 20, 25, 30, 35, and 40
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Mercincavage, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine content in people with Smoking, 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 15 Oct 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Daily cigarette consumption (time frame: Days 0 through 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.