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Addictive Potential of LCCs in Dual Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03496077
Recruitment Status : Suspended (COVID outbreak)
First Posted : April 12, 2018
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Erin Mead, UConn Health

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Dual Tobacco Use Tobacco Dependence Smoking Smoking, Cigar Smoking, Cigarette Smoking, Tobacco Other: Flavored and unflavored little cigars/cigarillos (LCCs) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized cross-over study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Addictive Potential of Little Cigars/Cigarillos in Dual Users: Effect by Flavor and Gender
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

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




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496077


Locations
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United States, Connecticut
UConn Health
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Investigators
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Principal Investigator: Erin L Mead, PhD,MHS UConn Health, Farmington, CT
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Responsible Party: Erin Mead, Assistant Professor, UConn Health
ClinicalTrials.gov Identifier: NCT03496077    
Other Study ID Numbers: 18-091-1
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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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
Keywords provided by Erin Mead, UConn Health:
Dual Use
Little Cigars and Cigarillos
Cigarettes
Flavored Tobacco Use
Addiction Potential
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders