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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Tobacco Use Disorder

• NCT number: NCT04487470
• Study type: Interventional
• Source: UConn Health
• Contact: Adam Flores, RA 1
• Phone: (860)305-3061
• Email: adflores@uchc.edu
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2020
• Completion date: May 31, 2024