Impact of Cigar Flavor in Dual Users

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04487470
• Other study ID #: 19-202-2
• Secondary ID: K01DA048494
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: UConn Health
• Contact: Adam Flores, RA 1
• Phone: (860)305-3061
• Email: adflores[@]uchc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Other:
• Flavored filtered cigars
Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase
• Unflavored filtered cigars
Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase

Locations

Country	Name	City	State
United States	UConn Health	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in saliva cotinine levels	Saliva samples will be analyzed for cotinine levels	3-5 weeks
Other	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
Primary	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
Primary	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
Primary	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	Change in exhaled breath carbon monoxide (CO) level	Daily exhaled breath CO measured over the course of the study period	3-5 weeks