Addictive Potential of LCCs in Dual Users

Study Overview
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Brief Summary
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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.

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

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

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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized cross-over study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flavored LCCs<br>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. | Other: Flavored and unflavored little cigars/cigarillos (LCCs)<br>* Flavored and unflavored LCCs that are currently available for purchase<br>|
| Experimental: Unflavored LCCs<br>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. | Other: Flavored and unflavored little cigars/cigarillos (LCCs)<br>* Flavored and unflavored LCCs that are currently available for purchase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual Use, Little Cigars and Cigarillos, Cigarettes, Flavored Tobacco Use, Addiction Potential