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Addictive Potential of LCCs in Dual Users

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ClinicalTrials.gov Identifier: NCT03496077
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Erin Mead, UConn Health

Tracking Information
First Submitted Date  ICMJE April 5, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date July 16, 2020
Actual Study Start Date  ICMJE July 2, 2018
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addictive Potential of LCCs in Dual Users
Official Title  ICMJE Addictive Potential of Little Cigars/Cigarillos in Dual Users: Effect by Flavor and Gender
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized cross-over study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Tobacco Use Disorder
  • Dual Tobacco Use
  • Tobacco Dependence
  • Smoking
  • Smoking, Cigar
  • Smoking, Cigarette
  • Smoking, Tobacco
Intervention  ICMJE Other: Flavored and unflavored little cigars/cigarillos (LCCs)
Flavored and unflavored LCCs that are currently available for purchase
Study Arms  ICMJE
  • 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.
    Intervention: Other: Flavored and unflavored little cigars/cigarillos (LCCs)
  • 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.
    Intervention: Other: Flavored and unflavored little cigars/cigarillos (LCCs)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2018)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 34 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Harriet L Zawistowski, Bachelor's 860-679-1658 zawistowski@uchc.edu
Contact: Erin L Mead, PhD,MHS 860-679-2456 mead@uchc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03496077
Other Study ID Numbers  ICMJE 18-091-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erin Mead, UConn Health
Study Sponsor  ICMJE UConn Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erin L Mead, PhD,MHS UConn Health, Farmington, CT
PRS Account UConn Health
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP