Dual Tobacco Use, Smoking, Smoking, Cigar, Smoking, Cigarette, Smoking, Tobacco, Tobacco Dependence, Tobacco Use Disorder
Conditions
Keywords
Dual Use, Little Cigars and Cigarillos, Cigarettes, Flavored Tobacco Use, Addiction Potential
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.
Interventions
OTHERFlavored and unflavored little cigars/cigarillos (LCCs)
Flavored and unflavored LCCs that are currently available for purchase
Sponsors
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized cross-over study
Eligibility
Sex/Gender
ALL
Age
18 Years to 34 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demand Elasticity | Post-treatment (after being assigned to use it for 7 days) | Hypothetical consumption of LCCs as prices increase. These are the model-adjusted predicted mean values of elasticity, adjusted for covariates. It is the expected change in consumption for a one unit change in price. |
| Demand Intensity | Post-treatment (after 7 days of being assigned to condition) | Hypothetical consumption when free. These are the model-adjusted predicted mean values of intensity, adjusted for covariates. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErin L Mead, PhD,MHS
UConn Health, Farmington, CT
Participant flow
Recruitment details
From August 2018-December 2020, we enrolled young adults, ages 18-34 years, who smoked both FCCs and cigarettes in central Connecticut using print and online media (e.g., Facebook, Craigslist), radio, and word-of-mouth.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 24.6 years STANDARD_DEVIATION 4.9 |
| Annual household income <$10,000 | 10 Participants |
| Annual household income $10,000-24,999 | 9 Participants |
| Annual household income $25,000-49,999 | 6 Participants |
| Annual household income $50,000 or more | 7 Participants |
| Heaviness of cigarette smoking in previous 30 days (# days smoked X mean per day) | 127.6 days*mean cigarettes/day STANDARD_DEVIATION 227.3 |
| Heaviness of cigar smoking in previosu 30 days (# days smoked X mean per day) | 64.8 days*avg cigars per day STANDARD_DEVIATION 86 |
| Highest educational attainment Greater than high school/GED | 15 Participants |
| Highest educational attainment No high school degree, or high school/GED completed | 35 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black or African American | 14 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 14 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 51 Participants |
| Smokes flavored cigars No | 11 Participants |
| Smokes flavored cigars Yes | 54 Participants |
| Smokes menthol cigarettes No | 21 Participants |
| Smokes menthol cigarettes Yes | 21 Participants |
| Subjective financial situation Just or don't meet basic needs | 17 Participants |
| Subjective financial situation Live comfortably | 11 Participants |
| Subjective financial situation Meet needs with a little left | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 53 |
| other Total, other adverse events | 1 / 54 | 6 / 53 |
| serious Total, serious adverse events | 0 / 54 | 0 / 53 |
Outcome results
None listed