Cigar Packaging Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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STUDY 3: A Multidisciplinary Examination of the Effects of Cigarillo Package Quantity on Consumption, Purchase Intentions, Risk Perceptions, Use and Exposure

Conditions
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Smoking

Intervention / Treatment
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* Other: Package Quantity (cigarillos)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 cigarillos per pack<br>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)<br>* 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.<br>|
| Experimental: 4 cigarillos per pack<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cigarillo, Behavior