Impact of Cigar Flavor in Dual Users

Sponsor
UConn Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04487470
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
145
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2
47.2
3.1

Study Details

Study Description

Brief Summary

The purpose of this remote study is to understand addiction to filtered cigars (FCs) compared to cigarettes in young adults 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. Prior to conducting the study, we will conduct a pilot phase to test baseline procedures.

Condition or Disease Intervention/Treatment Phase
  • Other: Flavored filtered cigars
  • Other: Unflavored filtered cigars
N/A

Detailed Description

The purpose of this remote study is to understand addiction to filtered cigars (FCs) compared to cigarettes in young adults 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 assigned a flavored or unflavored FC and then switched 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. All procedures will be conducted remotely by phone, computer, and mail.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
145 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized cross-over studyRandomized cross-over study
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Impact of Cigar Flavor on Tobacco Use Behaviors and Addiction in Dual Users
Actual Study Start Date :
Jun 24, 2020
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in demand elasticity for preferred flavored filtered cigars [3-4 weeks]

    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.

  2. Change in demand elasticity for preferred unflavored filtered cigars [3-4 weeks]

    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. Change in cross price elasticity for filtered cigars and cigarettes [3-4 weeks]

    It is measured by the Cross-Price Purchase Task. It is the hypothetical consumption of flavored and unflavored filtered cigars as cigarette prices increase.

Secondary Outcome Measures

  1. Change in exhaled breath carbon monoxide (CO) level [3-4 weeks]

    Daily exhaled breath CO measured over the course of the study period

Other Outcome Measures

  1. Change in saliva cotinine levels [3-4 weeks]

    Saliva samples will be analyzed for cotinine levels

  2. Change in number of flavored cigars, unflavored cigars, and cigarettes smoked per day [3-4 weeks]

    Participants will record tobacco use daily on their mobile phones using an app.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 34 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 18-34 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 UConn Health Farmington Connecticut United States 06030

Sponsors and Collaborators

  • UConn Health
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Erin Mead, PhD,MHS, UConn Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erin Mead-Morse, Assistant Professor, UConn Health
ClinicalTrials.gov Identifier:
NCT04487470
Other Study ID Numbers:
  • 19-202-2
  • K01DA048494
First Posted:
Jul 27, 2020
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erin Mead-Morse, Assistant Professor, UConn Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2022