Addictive Potential of LCCs in Dual Users

Smoking Clinical Trial

Official title:

Addictive Potential of Little Cigars/Cigarillos in Dual Users: Effect by Flavor and Gender

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496077
• Other study ID #: 18-091-1
• Status: Completed
• Phase: N/A
• Start date: August 28, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is about whether or not little cigars and cigarillos cause or maintain addiction, and if flavors, such as fruit, make them more addictive. The purpose of this study is to understand the addiction potential of little cigars and cigarillos compared to cigarettes in young adults who smoke both products. This study will also look at the differences between men and women. In the rest of this form, little cigars or cigarillos will be referred to as LCCs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

• Current regular dual user of little cigars/cigarillos (LCCs) and cigarettes, defined as: (a) report smoking cigarettes on = 8 of the past 30 days, and (b) report smoking unaltered LCCs (without marijuana) on = 8 of the past 30 days.
• Able to speak, read and understand English
• Age 18-34 years of age
• Stable residence (not planning to move during study period)
• Not intending to quit smoking cigarettes or LCCs within the next 2 weeks
• An expired carbon monoxide (CO) level of at least 4 ppm of expired air to verify smoking status

Exclusion Criteria:

• Pregnant for women (verified by urine pregnancy test at Visits 1 and 2)
• Current use of (or plans to use in the next 2-3 weeks) nicotine replacement products or cessation products (e.g., bupropion) to minimize confounding effects of another product)
• Positive breath alcohol screen (breath alcohol level (BAL) > 0 g/ml; one re-test allowed; assessed at Visits 1, 2, and 3)
• Illicit drug use other than marijuana (verified by positive drug toxicology test at Visits 1 and 3; one re-test allowed)
• Met criteria for Cannabis Dependence assessed by the Cannabis Use Disorders Identification Test-Revised (CUDIT-R)

Related Conditions & MeSH terms

• Dual Tobacco Use
• Smoking
• Smoking, Cigar
• Smoking, Cigarette
• Smoking, Tobacco
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Other:
• Flavored and unflavored little cigars/cigarillos (LCCs)
Flavored and unflavored LCCs that are currently available for purchase

Locations

Country	Name	City	State
United States	UConn Health	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
UConn Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demand elasticity for preferred flavor LCCs	It is measured by the Cigarette Purchase Task, which will be adapted to assess this product. It is the hypothetical consumption of preferred flavor LCCs as increasing prices on a log-log scale.	Post-treatment (after being assigned to use it for 7 days)
Primary	Demand elasticity for unflavored LCCs	It is measured by the Cigarette Purchase Task, which will be adapted to assess this product. It is the hypothetical consumption of unflavored LCCs as increasing prices on a log-log scale.	Post-treatment (after being assigned to use it for 7 days)