Cigar Packaging Study

NCT04605874 | Completed

• 3 other identifiers: UPCC 020211U54CA229973834476
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

Cigarillo, Behavior

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Subjective Cigarillo Ratings (Visual Analog Scale [VAS] of Cigarillo Characteristics)

  Day 5 through Day 20

• Cigarillo Craving (Questionnaire on Smoking Urges [QSU])

  Day 0 through Day 20

• Cigarillo Withdrawal (Withdrawal Symptom Checklist [WSC])

  Day 0 through Day 20

• Cigar Evaluation (Cigar Evaluation Scale [CES])

  Day 5 through Day 20

• Sensory Measure (Sensory Questionnaire [SQ])

  Day 5 through Day 20

Study Arms (2)

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.

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.

Other: Package Quantity (cigarillos)

Interventions

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.

2 cigarillos per pack; 4 cigarillos per pack

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Center for Interdisciplinary Research for Nicotine Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Smoking; Behavior

Interventions

Tobacco Products

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Andrew Strasser, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 28, 2020
• Study Start: March 5, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 year after the conclusion of recruitment.
• Access Criteria: Researchers should contact the Principal Investigator via email.

Locations

US (1)