SmokingCPSNCT04605874
Cigar Packaging Study
A study testing Package Quantity (cigarillos) 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 examine the effect of number of cigarillos per package on use behaviors, intensity of use and biomarkers of exposure. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Smoking
- What is being tested?
- Package Quantity (cigarillos)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2020to 15 Dec 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current cigarillo smoker (i.e., smoked at least 50 cigarillos in their lifetime)
- Not currently undergoing smoking cessation treatment or planning to quit smoking over the duration of the study (~3 weeks).
- Plan to live in the area for the duration of the study.
- Willing to use study provided cigarillos.
- Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the combined Informed Consent and HIPAA form.
- Able to communicate fluently in English (i.e., speaking, writing, and reading).
Who cannot join
- Use of any nicotine-containing products other than cigarillos or cigarettes. Participants reporting isolated use of other nicotine containing products less than 5 times per month are eligible to participate.
- Current or impending enrollment in a smoking cessation program. Further, participants will be excluded for an attempt to quit smoking over the duration of the study period.
- History of substance abuse (other than nicotine dependence) 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.
- 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 impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
Show all 14Show fewer
- Serious or unstable medical condition. Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
- Lifetime history or current diagnosis of COPD, cardiovascular disease, or heart attack.
- Lifetime history of schizophrenia, psychosis, and/or bipolar disorder.
- Current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate.
- Additional, general reasons for exclusion include:
- 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 circumstance, 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. Participants may be withdrawn for any of the aforementioned reasons at any point throughout the study.
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. 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 for Nicotine Addiction
Philadelphia, Pennsylvania, 19104
About this study
Official title: STUDY 3: A Multidisciplinary Examination of the Effects of Cigarillo Package Quantity on Consumption, Purchase Intentions, Risk Perceptions, Use and Exposure
The purpose of this study is to examine the effect of number of cigarillos per package on use behaviors, intensity of use and biomarkers of exposure.
Read the detailed description
This laboratory-based study will aim to enroll 50 current cigarillo users to complete a 20-day, randomized, parallel design protocol. After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack, to examine how quantity per pack affects use patterns, including daily consumption and cigar smoking topography. Participants will be asked to attend 2 in-person sessions on Days 5 and 20. On Days 0, 9, 12 and 16 participants will complete sessions with research staff remotely (i.e. by phone or video call). Sessions will occur every 3-5 days, for a total of 6 sessions across 20 days.
- Conditions
- Smoking
- Being tested
- Package Quantity (cigarillos)
- Keywords
- Cigarillo, Behavior
- Medical subject headings
- Smoking, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Package Quantity (cigarillos)Other
After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack.
| Study group | Role | What they receive |
|---|---|---|
| 2 cigarillos per pack | Experimental | After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to receive 2 cigarillos per pack. Receives: Other: Package Quantity (cigarillos) |
| 4 cigarillos per pack | Experimental | After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to receive 4 cigarillos per pack. Receives: Other: Package Quantity (cigarillos) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Cigarillo Consumption
Daily cigarillo consumption will be assessed by participant self-report throughout the 20-day study duration and verified through the collection of spent cigarillo "tips/ends" for all cigarillos smoked throughout the 15-day experimental period.
Measured: Day 0 through Day 20
Smoking Topography
Topography data will be produced through a standardized video scoring procedure. Participants will video recorded to collect smoking topography data for all cigarillos smoked throughout the 15-day experimental period.
Measured: Day 5 through Day 20
Total Nicotine Equivalents
Urine collected at Day 5 and Day 20 will be assessed for changes in total nicotine equivalents, nicotine plus its primary metabolites, across the experimental study period (Days 5-20). Total nicotine equivalents will be measured in nanograms per milliliter (ng per mL).
Measured: Days 5 and 20
Total NNAL
Urine collected at Day 5 and Day 20 will be assessed for changes in NNAL, a biomarker of carcinogen exposure, across the experimental study period (Days 5-20). Total NNAL will be measured in nanograms per milliliter (ng per mL).
Measured: Days 5 and 20
Secondary outcomes (5)
Subjective Cigarillo Ratings (Visual Analog Scale [VAS] of Cigarillo Characteristics)
Participants will provide subjective ratings of each cigarillo smoked during each session using a 14-item, 100 mm visual analog scale (VAS) of cigarette characteristics. Anchors are item-specific (e.g., taste: 0 = "very bad," 100 = "very good"), with lower scores indicating less favorable ratings.
Measured: Day 5 through Day 20
Cigarillo Craving (Questionnaire on Smoking Urges [QSU])
Participants will report cigarillo craving at the onset of each session. 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 a 32-item Questionnaire on Smoking Urges (QSU). Participants will respond to each item along a 7-point scale (1=Strongly disagree; 7=Strongly agree).
Measured: Day 0 through Day 20
Cigarillo Withdrawal (Withdrawal Symptom Checklist [WSC])
Participants will report cigarillo withdrawal at the onset of each session. Withdrawal will be assessed using a summary score from the 20-item (21 items at Session 1 [Day 0]) revised version of the Withdrawal Symptom Checklist with a one-week frame of reference (WSC-W). Specifically, participants will respond regarding to how they felt in regards to each potential withdrawal symptom along a 4-point scale (0=Not Present; 3=Severe).
Measured: Day 0 through Day 20
Cigar Evaluation (Cigar Evaluation Scale [CES])
Participants will complete an 11-item questionnaire in regard to the cigarillo smoked during each session. Items on the questionnaire include subjective measures concerning taste, satisfaction, and physical effects.
Measured: Day 5 through Day 20
Sensory Measure (Sensory Questionnaire [SQ])
Participants will complete a 9-item questionnaire in regard to the cigarillo smoked during each session. Items on the questionnaire include subjective measures concerning puffs (e.g., satisfaction, perceived levels of nicotine, etc.) and puff sensations (i.e., how strong puffs were in a number of places such as the chest and nose).
Measured: Day 5 through Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start5 Mar 2020
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
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.
- 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
- Parallel groups
- Model description
- This project will recruit current cigarillo users to a 20-day, randomized, parallel design protocol. After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack, to examine how quantity per pack affects use patterns, including daily consumption and cigar smoking topography.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Andrew Strasser, Abramson Cancer Center at Penn Medicine
- Investigators
- Andrew Strasser, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605874
- Sponsor's protocol ID
- UPCC 02021
- Other IDs
- 1U54CA229973, 834476
- Acronym
- CPS
- Status last verified
- Feb 2023
- First submitted
- 21 Oct 2020
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified study data will be made available to other researchers who contact the project Principal Investigator via email. Data will be available to such requests 1 year after the conclusion of recruitment.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY 3: A Multidisciplinary Examination of the Effects of Cigarillo Package Quantity on Consumption, Purchase Intentions, Risk Perceptions, Use and Exposure
- ClinicalTrials.gov ID
- NCT04605874
- Acronym / sponsor ID
- CPS / UPCC 02021
- Conditions
- Smoking
- Keywords
- Cigarillo, Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 28 Oct 2020 (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 examine the effect of number of cigarillos per package on use behaviors, intensity of use and biomarkers of exposure.
Detailed description
This laboratory-based study will aim to enroll 50 current cigarillo users to complete a 20-day, randomized, parallel design protocol. After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack, to examine how quantity per pack affects use patterns, including daily consumption and cigar smoking topography. Participants will be asked to attend 2 in-person sessions on Days 5 and 20. On Days 0, 9, 12 and 16 participants will complete sessions with research staff remotely (i.e. by phone or video call). Sessions will occur every 3-5 days, for a total of 6 sessions across 20 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This project will recruit current cigarillo users to a 20-day, randomized, parallel design protocol. After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack, to examine how quantity per pack affects use patterns, including daily consumption and cigar smoking topography.
| Arm | Type | Receives |
|---|---|---|
| 2 cigarillos per pack | Experimental | Other: Package Quantity (cigarillos)After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to receive 2 cigarillos per pack. |
| 4 cigarillos per pack | Experimental | Other: Package Quantity (cigarillos)After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to receive 4 cigarillos per pack. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current cigarillo smoker (i.e., smoked at least 50 cigarillos in their lifetime)
- Not currently undergoing smoking cessation treatment or planning to quit smoking over the duration of the study (~3 weeks).
- Plan to live in the area for the duration of the study.
- Willing to use study provided cigarillos.
- Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the combined Informed Consent and HIPAA form.
Key exclusion criteria (14 listed)
- Use of any nicotine-containing products other than cigarillos or cigarettes. Participants reporting isolated use of other nicotine containing products less than 5 times per month are eligible to participate.
- Current or impending enrollment in a smoking cessation program. Further, participants will be excluded for an attempt to quit smoking over the duration of the study period.
- History of substance abuse (other than nicotine dependence) 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.
- 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.
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 |
|---|---|---|
| Package Quantity (cigarillos)After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack. | Other | 2 cigarillos per pack, 4 cigarillos per pack |
Primary outcome
Daily Cigarillo Consumption
Time frame: Day 0 through Day 20
Daily cigarillo consumption will be assessed by participant self-report throughout the 20-day study duration and verified through the collection of spent cigarillo "tips/ends" for all cigarillos smoked throughout the 15-day experimental period.
Smoking Topography
Time frame: Day 5 through Day 20
Topography data will be produced through a standardized video scoring procedure. Participants will video recorded to collect smoking topography data for all cigarillos smoked throughout the 15-day experimental period.
Total Nicotine Equivalents
Time frame: Days 5 and 20
Urine collected at Day 5 and Day 20 will be assessed for changes in total nicotine equivalents, nicotine plus its primary metabolites, across the experimental study period (Days 5-20). Total nicotine equivalents will be measured in nanograms per milliliter (ng per mL).
Total NNAL
Time frame: Days 5 and 20
Urine collected at Day 5 and Day 20 will be assessed for changes in NNAL, a biomarker of carcinogen exposure, across the experimental study period (Days 5-20). Total NNAL will be measured in nanograms per milliliter (ng per mL).
5 secondary outcomes
Subjective Cigarillo Ratings (Visual Analog Scale [VAS] of Cigarillo Characteristics)
Time frame: Day 5 through Day 20
Cigarillo Craving (Questionnaire on Smoking Urges [QSU])
Time frame: Day 0 through Day 20
Cigarillo Withdrawal (Withdrawal Symptom Checklist [WSC])
Time frame: Day 0 through Day 20
Cigar Evaluation (Cigar Evaluation Scale [CES])
Time frame: Day 5 through Day 20
Sensory Measure (Sensory Questionnaire [SQ])
Time frame: Day 5 through Day 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: Yes. Deidentified study data will be made available to other researchers who contact the project Principal Investigator via email. Data will be available to such requests 1 year after the conclusion of recruitment.
Related trials for Smoking
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Recruiting
Feasibility and Uptake of Low-Dose CT Lung Cancer Screening in Kuwait
Lung Cancer, Lung Neoplasms
Not yet recruiting
Studying Different Ways of Using Oral Nicotine Pouches to Understand the Effect on Nicotine Delivery, Appeal, and Side Effects Among Adult Cigarette Smokers
Cigarette Smoking-Related Carcinoma
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
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.
Andrew Strasser, Ph.D. 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 Package Quantity (cigarillos) 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 6 inclusion and 14 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 27 Feb 2023. 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?
Daily Cigarillo Consumption (time frame: Day 0 through Day 20). The study lists 4 primary outcomes in all. 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 27 Feb 2023.