Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U54CA229973 | U.S. NIH Grant/Contract | View source | |
| 834476 | Other Identifier | IRB protocol number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | 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). | Days 5 and 20 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 5 through Day 20 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Additional, general reasons for exclusion include:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrew Strasser, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Interdisciplinary Research for Nicotine Addiction | Philadelphia | Pennsylvania | 19104 | United States |
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.
1 year after the conclusion of recruitment.
Researchers should contact the Principal Investigator via email.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 30, 2021 | Nov 22, 2022 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
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.
Not provided
Not provided
Participants will be informed that they will be supplied with study cigarillos, but will be unaware of their randomization condition, 2 cigarillos per pack versus 4 cigarillos per pack.
| 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). | 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). | 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. | 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). | Day 5 through Day 20 |