Cigar Packaging Study (CPS)

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: Package Quantity (cigarillos)

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Center for Interdisciplinary Research for Nicotine Addiction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2 cigarillos per pack; 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.	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 one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack.
Experimental: 4 cigarillos per pack; 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.	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 one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Andrew Strasser, Ph.D., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cigarillo, Behavior
• Other Study ID Numbers: UPCC 02021; 1U54CA229973 (U.S. NIH Grant/Contract); 834476 (Other Identifier: IRB protocol number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 1 year after the conclusion of recruitment.
• IPD Sharing Access Criteria: Researchers should contact the Principal Investigator via email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No