Addictive Potential of LCCs in Dual Users

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flavored 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.	Other: Flavored and unflavored little cigars/cigarillos (LCCs); Flavored and unflavored LCCs that are currently available for purchase
Experimental: Unflavored 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.	Other: Flavored and unflavored little cigars/cigarillos (LCCs); Flavored and unflavored LCCs that are currently available for purchase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demand Elasticity	Hypothetical consumption of LCCs as prices increase. These are the model-adjusted predicted mean values of elasticity, adjusted for covariates. It is the expected change in consumption for a one unit change in price.	Post-treatment (after being assigned to use it for 7 days)
Demand Intensity	Hypothetical consumption when free. These are the model-adjusted predicted mean values of intensity, adjusted for covariates.	Post-treatment (after 7 days of being assigned to condition)

Collaborators and Investigators

• Sponsor: UConn Health
• Investigators: Principal Investigator: Erin L Mead, PhD,MHS, UConn Health, Farmington, CT

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cigarettes; Dual Use; Little Cigars and Cigarillos; Flavored Tobacco Use; Addiction Potential
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Tobacco Use; Tobacco Use Disorder; Smoking; Cigarette Smoking; Tobacco Smoking; Cigar Smoking; Pharmaceutical Preparations; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Manufactured Materials; Technology, Industry, and Agriculture; Specialty Uses of Chemicals; Pharmaceutic Aids; Smoking Devices; Food Additives; Food Ingredients; Tobacco Products; Flavoring Agents
• Other Study ID Numbers: 18-091-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No