Addictive Potential of LCCs in Dual Users

NCT ID: NCT03496077

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2020-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Flavored and unflavored little cigars/cigarillos (LCCs)

Intervention Type: OTHER

Flavored and unflavored LCCs that are currently available for purchase

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.

Group Type: EXPERIMENTAL

Flavored and unflavored little cigars/cigarillos (LCCs)

Intervention Type: OTHER

Flavored and unflavored LCCs that are currently available for purchase

Interventions

Flavored and unflavored little cigars/cigarillos (LCCs)

Flavored and unflavored LCCs that are currently available for purchase

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Erin Mead-Morse

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin L Mead, PhD,MHS

Role: PRINCIPAL_INVESTIGATOR

UConn Health, Farmington, CT

Locations

UConn Health

Farmington, Connecticut, United States

Countries

United States

Other Identifiers

18-091-1

Identifier Type: -

Identifier Source: org_study_id