Back to resultsAddictive Potential of LCCs in Dual Users
Primary Purpose
Tobacco Use Disorder, Dual Tobacco Use, Tobacco Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flavored and unflavored little cigars/cigarillos (LCCs)
Sponsored by
About this trial
This is an interventional other trial for Tobacco Use Disorder focused on measuring Dual Use, Little Cigars and Cigarillos, Cigarettes, Flavored Tobacco Use, Addiction Potential
Eligibility Criteria
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)
Sites / Locations
- UConn Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Flavored LCCs
Unflavored LCCs
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03496077
Brief Title
Addictive Potential of LCCs in Dual Users
Official Title
Addictive Potential of Little Cigars/Cigarillos in Dual Users: Effect by Flavor and Gender
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized cross-over study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flavored LCCs
Arm Type
Experimental
Arm 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.
Arm Title
Unflavored LCCs
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Flavored and unflavored little cigars/cigarillos (LCCs)
Intervention Description
Flavored and unflavored LCCs that are currently available for purchase
Primary Outcome Measure Information:
Title
Demand elasticity for preferred flavor LCCs
Description
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.
Time Frame
Post-treatment (after being assigned to use it for 7 days)
Title
Demand elasticity for unflavored LCCs
Description
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.
Time Frame
Post-treatment (after being assigned to use it for 7 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin L Mead, PhD,MHS
Organizational Affiliation
UConn Health, Farmington, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Addictive Potential of LCCs in Dual Users
We'll reach out to this number within 24 hrs