Addictive Potential of LCCs in Dual Users

UConn Health

Status: Completed

Conditions: Tobacco Dependence; Dual Tobacco Use; Smoking, Cigarette; Tobacco Use Disorder; Smoking, Cigar; Smoking, Tobacco; Smoking

Treatments: Other: Flavored and unflavored little cigars/cigarillos (LCCs)

Study type: Interventional

Funder types: Other

Identifiers

NCT03496077

18-091-1

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Flavored LCCs

Experimental group

Description:

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.

Treatment:

Other: Flavored and unflavored little cigars/cigarillos (LCCs)

Unflavored LCCs

Experimental group

Description:

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.

Treatment:

Other: Flavored and unflavored little cigars/cigarillos (LCCs)