Addictive Potential of LCCs in Dual Users

Overview

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.

Full Title of Study: “Addictive Potential of Little Cigars/Cigarillos in Dual Users: Effect by Flavor and Gender”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Other: Flavored and unflavored little cigars/cigarillos (LCCs)
    • Flavored and unflavored LCCs that are currently available for purchase

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Demand elasticity for preferred flavor LCCs
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 34 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • UConn Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Erin Mead-Morse, Assistant Professor – UConn Health
  • Overall Official(s)
    • Erin L Mead, PhD,MHS, Principal Investigator, UConn Health, Farmington, CT

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.