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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flavored LCCs | Experimental | 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. |
|
| Unflavored LCCs | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavored and unflavored little cigars/cigarillos (LCCs) | Other | Flavored and unflavored LCCs that are currently available for purchase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demand Elasticity | 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. | Post-treatment (after being assigned to use it for 7 days) |
| Demand Intensity | Hypothetical consumption when free. These are the model-adjusted predicted mean values of intensity, adjusted for covariates. | Post-treatment (after 7 days of being assigned to condition) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin L Mead, PhD,MHS | UConn Health, Farmington, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Farmington | Connecticut | 06030 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flavored LCCs First, Then Unflavored 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. Flavored and unflavored little cigars/cigarillos (LCCs): Flavored and unflavored LCCs that are currently available for purchase |
| FG001 | Unflavored LCCs First, Then Flavored 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. Flavored and unflavored little cigars/cigarillos (LCCs): Flavored and unflavored LCCs that are currently available for purchase |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Flavored LCCs First, Then Unflavored 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. Flavored and unflavored little cigars/cigarillos (LCCs): Flavored and unflavored LCCs that are currently available for purchase |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Demand Elasticity | 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. | This was a within-subjects crossover study. N=47 participants were analyzed for this outcome, and all of them received the flavored cigarillo intervention and the unflavored cigarette intervention in random order. n=23 received flavored cigarillos first then unflavored cigarillos, and n=24 received unflavored cigarillos first then flavored cigarillos. | Posted | Mean | 95% Confidence Interval | cigarettes/dollar | Post-treatment (after being assigned to use it for 7 days) |
|
About 3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flavored Cigarillos | Assigned to flavored cigarillos for 7-days | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory effects | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Increased shortness of breath, throat/lung irritation, cough, phlegm, or runny nose, or has a cold. Moderately to severe effects only. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erin Mead-Morse | UConn Health | 860-679-8949 | mead@uchc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2021 | Mar 5, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D000073863 | Cigar Smoking |
| D000073865 | Cigarette Smoking |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005421 | Flavoring Agents |
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
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Randomized cross-over study
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| BG001 |
| Unflavored LCCs First, Then Flavored 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. Flavored and unflavored little cigars/cigarillos (LCCs): Flavored and unflavored LCCs that are currently available for purchase |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Heaviness of cigarette smoking in previous 30 days (# days smoked X mean per day) | Mean | Standard Deviation | days*mean cigarettes/day |
|
| Heaviness of cigar smoking in previosu 30 days (# days smoked X mean per day) | Mean | Standard Deviation | days*avg cigars per day |
|
| Smokes menthol cigarettes | Count of Participants | Participants |
|
| Smokes flavored cigars | Count of Participants | Participants |
|
| Annual household income | Count of Participants | Participants |
|
| Highest educational attainment | Count of Participants | Participants |
|
| Subjective financial situation | Count of Participants | Participants |
|
| Unflavored Cigarillos |
Assigned to unflavored cigarillos for 7-days |
|
|
| Primary | Demand Intensity | Hypothetical consumption when free. These are the model-adjusted predicted mean values of intensity, adjusted for covariates. | This was a within-subjects crossover study. N=47 participants were analyzed for this outcome, and all of them received the flavored cigarillo intervention and the unflavored cigarette intervention in random order. n=23 received flavored cigarillos first then unflavored cigarillos, and n=24 received unflavored cigarillos first then flavored cigarillos. | Posted | Mean | 95% Confidence Interval | mg of nicotine | Post-treatment (after 7 days of being assigned to condition) |
|
|
|
| 54 |
| 0 |
| 54 |
| 1 |
| 54 |
| EG001 | Unflavored Cigarillos | Assigned to unflavored cigarillos for 7-days | 0 | 53 | 0 | 53 | 6 | 53 |
|
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| D064424 |
| Tobacco Use |
| D020313 |
| Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |