Addictive Potential of LCCs in Dual Users

NCT03496077 | Completed Results

• 1 other identifier: 18-091-1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Dual Use; Little Cigars and Cigarillos; Cigarettes; Flavored Tobacco Use; Addiction Potential

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Flavored LCCs

EXPERIMENTAL

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)

Unflavored LCCs

EXPERIMENTAL

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)

Interventions

Flavored and unflavored little cigars/cigarillos (LCCs) OTHER

Flavored and unflavored LCCs that are currently available for purchase

Flavored LCCs; Unflavored LCCs

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Cigar Smoking; Cigarette Smoking; Tobacco Smoking

Interventions

Flavoring Agents; Tobacco Products

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Erin Mead-Morse
• Organization: UConn Health

mead@uchc.edu

860-679-8949

Study Officials

• Erin L Mead, PhD,MHS

  UConn Health, Farmington, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized cross-over study

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 12, 2018
• Study Start: August 28, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-03

Locations

US (1)