Clinical trial NCT04605874: Cigar Packaging Study
Official title: STUDY 3: A Multidisciplinary Examination of the Effects of Cigarillo Package Quantity on Consumption, Purchase Intentions, Risk Perceptions, Use and Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Cigarillo, Behavior
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-10-28
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Daily Cigarillo Consumption
timeFrame: Day 0 through Day 20
measure: Smoking Topography
timeFrame: Day 5 through Day 20
measure: Total Nicotine Equivalents
timeFrame: Days 5 and 20
measure: Total NNAL
timeFrame: Days 5 and 20
Secondary outcomes:
measure: Subjective Cigarillo Ratings (Visual Analog Scale [VAS] of Cigarillo Characteristics)
timeFrame: Day 5 through Day 20
measure: Cigarillo Craving (Questionnaire on Smoking Urges [QSU])
timeFrame: Day 0 through Day 20
measure: Cigarillo Withdrawal (Withdrawal Symptom Checklist [WSC])
timeFrame: Day 0 through Day 20
measure: Cigar Evaluation (Cigar Evaluation Scale [CES])
timeFrame: Day 5 through Day 20
measure: Sensory Measure (Sensory Questionnaire [SQ])
timeFrame: Day 5 through Day 20
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Interdisciplinary Research for Nicotine Addiction
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrew Strasser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: