Impact of Cigar Flavor in Dual Users

Impact of Cigar Flavor on Tobacco Use Behaviors and Addiction in Dual Users

The purpose of this study is to understand addiction to filtered cigars (FCs) compared to cigarettes in young adults, ages 21-34, who smoke both cigarettes and cigars. We are also looking to see if flavors, such as fruit or menthol, make FCs more addictive and if there are differences between men and women. Participants will receive 2 weeks supply of FCs, one week flavored and another week unflavored. You will be randomized (like flipping a coin) to which type of FC you will receive first. The study will:

• take about 3-4 hours of your time per week over 3-5 weeks.
• be conducted remotely by phone, video call, email, and mail.
• require a smart phone to answer 5 quick surveys a day
• you will need to answer 4 weekly surveys
• take part in a weekly video or phone call with research staff
• supply three saliva samples to be later tested for nicotine and other toxicants
• and use a device to measure your carbon monoxide levels four times a day.

You will be compensated for your time.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Other: Flavored filtered cigars; Other: Unflavored filtered cigars

Detailed Description

The purpose of this remote study is to understand addiction to filtered cigars (FCs) compared to cigarettes in young adults, ages 21-34, who are dual users of cigarettes and cigars, if flavor, such as fruit or menthol, makes FCs more addictive, and if there are differences for men and women. The first hypothesis is that the potential for FCs to cause addiction will be lower than that of cigarettes but will increase as cigarette cost increases. Second, flavored FCs will be more addictive than unflavored FCs, and that the effect of flavored FCs on addiction will be greater in women than men. Last, participants will smoke more FCs and fewer cigarettes when given flavored compared to unflavored FCs. This study employs a crossover design (controlled for menthol status) in which 145 young adult dual users will be randomized to a flavored or unflavored FC that will be provided and then switch to the other type after 1 week. We will utilize the Cigarette Purchase Task, other standardized measures of dependence, and ecological momentary assessments to study the relationship between dependence indicators and smoking in the natural environment. Participation will take 3-4 hours of time per week over 3-5 weeks. Participants will be asked to complete brief surveys on their mobile phone 5 times a day, every day, weekly surveys about tobacco use, attitudes, and beliefs, and take part in a weekly video or phone call with research staff. They will need to use a carbon monoxide device we provide, four times a day, and provide 3 saliva samples that will later be analyzed for nicotine and other toxicants. All procedures will be conducted remotely by phone, computer, and mail.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Current regular dual uses of filtered cigars and cigarillos (FCs) and cigarettes defined as; (a) report smoking cigarettes at least weekly in the past 30 days, (b) report smoking unaltered FC (without marijuana) at least weekly in the past 30 days; and (c)report cigarette and cigar use at their current rate (or more frequently) for ≥ 3 months.
• Able to read, speak, and understand English
• Age 21-34 years
• Stable residence (does not intend to move during the study period)
• Not intending to quit smoking during the study period
• Has a smart phone with a data plan (this study is being done remotely)
• Saliva cotinine level >30 ng/mL

Exclusion Criteria:

• Self-reported current pregnancy, currently trying to become pregnant, or breast-feeding
• Current use of nicotine replacement products or cessation products (e.g., bupropion) or plans to use in the next 3 weeks for the purposes of cessation.
• Diagnosed with or being treated for COPD, emphysema, and/or uncontrolled asthma as determined by research screening.
• Currently taking anti-hypertensive medications
• Currently has pneumonia, bronchitis, or COVID symptoms that has not yet resolved, or was hospitalized or visited the ER in the past 4 weeks for a respiratory-related illness that has not yet resolved (can be re-screened once resolved)
• Resident of Alaska, Hawaii, or Massachusetts

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flavored Filtered Cigars; Half of the group will be randomized to start with flavored filtered cigars (FCs) at the second visit and cross over to unflavored FCs at the third visit. FCs will be Cheyenne filtered cigars.	Other: Flavored filtered cigars; Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase
Experimental: Unflavored Filtered Cigars; Half of the group will be randomized to start with unflavored FCs at the second visit and cross over to flavored FCs at the third visit. FCs will be Cheyenne filtered cigars.	Other: Unflavored filtered cigars; Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in demand elasticity for preferred flavored filtered cigars	It is measured by the Cigarette Purchase Task, which will be adapted to assess these products. It is the hypothetical consumption of flavored cigars at increasing prices.	3-5 weeks
Change in demand elasticity for preferred unflavored filtered cigars	It is measured by the Cigarette Purchase Task, which will be adapted to assess these products. It is the hypothetical consumption of unflavored cigars at increasing prices.	3-5 weeks
Change in cross price elasticity for filtered cigars and cigarettes	It is measured by the Cross-Price Purchase Task. It is the hypothetical consumption of flavored and unflavored filtered cigars as cigarette prices increase.	3-5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exhaled breath carbon monoxide (CO) level	Daily exhaled breath CO measured over the course of the study period	3-5 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in saliva cotinine levels	Saliva samples will be analyzed for cotinine levels	3-5 weeks
Change in number of flavored cigars, unflavored cigars, and cigarettes smoked per day	Participants will record tobacco use daily on their mobile phones using an app.	3-5 weeks

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Erin Mead-Morse, PhD,MHS, UConn Health

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2020
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Smoking; Cigarette Smoking; Dual Tobacco Use; Cigar Smoking
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Tobacco Smoking; Tobacco Use; Tobacco Use Disorder; Smoking; Cigarette Smoking; Cigar Smoking
• Other Study ID Numbers: 19-202-2; K01DA048494 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A verified database will be available once the main findings from the final dataset have been reported and accepted for publication. Information that does result from our analysis of the saliva samples will be available after publication of the findings. De-identified dataset will contain the data merged from all study visits. We will include with the data file proper documentation of all data (including definitions of variables and derived variables, frequencies, details about codes, etc.), and procedures used to collect the data, to ensure others can use the dataset and to prevent misuse, misinterpretation, and/or confusion. The database intended for public distribution will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.
• IPD Sharing Time Frame: In the final year of the Award after the dataset is finalized we will prepare a file in Excel and Stata that contains all study variables intended for use in presentations and publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No