Impact of Cigar Flavor in Dual Users

NCT04487470 | Completed

• 2 other identifiers: 19-202-2K01DA048494
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use Disorder

Keywords

Dual Tobacco Use; Smoking; Cigar Smoking; Cigarette Smoking

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in exhaled breath carbon monoxide (CO) level

  3-5 weeks

Other Outcomes (2)

• Change in saliva cotinine levels

  3-5 weeks

• Change in number of flavored cigars, unflavored cigars, and cigarettes smoked per day

  3-5 weeks

Study Arms (2)

Flavored Filtered Cigars

EXPERIMENTAL

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

Unflavored Filtered Cigars

EXPERIMENTAL

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

Interventions

Flavored filtered cigars OTHER

Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase

Flavored Filtered Cigars

Unflavored filtered cigars OTHER

Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase

Unflavored Filtered Cigars

Eligibility Criteria

• Age: 21 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Cigar Smoking; Cigarette Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Tobacco Smoking; Tobacco Use

Study Officials

• Erin Mead-Morse, PhD,MHS

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized cross-over study

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 27, 2020
• Study Start: June 24, 2020
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)