Addictive Potential of LCCs in Dual Users

Not Applicable

Completed

• Conditions: Tobacco Use Disorder; Tobacco Dependence; Smoking, Cigar; Smoking; Smoking, Cigarette; Dual Tobacco Use; Smoking, Tobacco
• Interventions: Other: Flavored and unflavored little cigars/cigarillos (LCCs)

• Registration Number: NCT03496077
• Lead Sponsor: UConn Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-12
• Study Start: 2018-08-28
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Unflavored LCCs	Flavored and unflavored little cigars/cigarillos (LCCs)	Half of the group will start with an unflavored little cigar/cigarillo (LCC) and cross over to flavored LCC. The LCCs will be a popular brand already available for sale on the market.
Flavored LCCs	Flavored and unflavored little cigars/cigarillos (LCCs)	Half of the group will start with a flavored little cigar/cigarillo (LCC) and cross over to unflavored LCC. The LCCs will be a popular brand already available for sale on the market.

Primary Outcome Measures

Name	Time	Method
Demand elasticity for preferred flavor LCCs	Post-treatment (after being assigned to use it for 7 days)	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.
Demand elasticity for unflavored LCCs	Post-treatment (after being assigned to use it for 7 days)	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.

Trial Locations

Locations (1)

UConn Health; 🇺🇸 Farmington, Connecticut, United States