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| ID | Type | Description | Link |
|---|---|---|---|
| K01DA048494 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to understand addiction to filtered cigars (FCs) compared to cigarettes in young adults, ages 21-34, who smoke both cigarettes and cigars. We are also looking to see if flavors, such as fruit or menthol, make FCs more addictive and if there are differences between men and women. Participants will receive 2 weeks supply of FCs, one week flavored and another week unflavored. You will be randomized (like flipping a coin) to which type of FC you will receive first. The study will:
You will be compensated for your time.
The purpose of this remote study is to understand addiction to filtered cigars (FCs) compared to cigarettes in young adults, ages 21-34, who are dual users of cigarettes and cigars, if flavor, such as fruit or menthol, makes FCs more addictive, and if there are differences for men and women. The first hypothesis is that the potential for FCs to cause addiction will be lower than that of cigarettes but will increase as cigarette cost increases. Second, flavored FCs will be more addictive than unflavored FCs, and that the effect of flavored FCs on addiction will be greater in women than men. Last, participants will smoke more FCs and fewer cigarettes when given flavored compared to unflavored FCs. This study employs a crossover design (controlled for menthol status) in which 145 young adult dual users will be randomized to a flavored or unflavored FC that will be provided and then switch to the other type after 1 week. We will utilize the Cigarette Purchase Task, other standardized measures of dependence, and ecological momentary assessments to study the relationship between dependence indicators and smoking in the natural environment. Participation will take 3-4 hours of time per week over 3-5 weeks. Participants will be asked to complete brief surveys on their mobile phone 5 times a day, every day, weekly surveys about tobacco use, attitudes, and beliefs, and take part in a weekly video or phone call with research staff. They will need to use a carbon monoxide device we provide, four times a day, and provide 3 saliva samples that will later be analyzed for nicotine and other toxicants. All procedures will be conducted remotely by phone, computer, and mail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flavored Filtered Cigars | Experimental | Half of the group will be randomized to start with flavored filtered cigars (FCs) at the second visit and cross over to unflavored FCs at the third visit. FCs will be Cheyenne filtered cigars. |
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| Unflavored Filtered Cigars | Experimental | Half of the group will be randomized to start with unflavored FCs at the second visit and cross over to flavored FCs at the third visit. FCs will be Cheyenne filtered cigars. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavored filtered cigars | Other | Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in demand elasticity for preferred flavored filtered cigars | It is measured by the Cigarette Purchase Task, which will be adapted to assess these products. It is the hypothetical consumption of flavored cigars at increasing prices. | 3-5 weeks |
| Change in demand elasticity for preferred unflavored filtered cigars | It is measured by the Cigarette Purchase Task, which will be adapted to assess these products. It is the hypothetical consumption of unflavored cigars at increasing prices. | 3-5 weeks |
| Change in cross price elasticity for filtered cigars and cigarettes | It is measured by the Cross-Price Purchase Task. It is the hypothetical consumption of flavored and unflavored filtered cigars as cigarette prices increase. | 3-5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in exhaled breath carbon monoxide (CO) level | Daily exhaled breath CO measured over the course of the study period | 3-5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in saliva cotinine levels | Saliva samples will be analyzed for cotinine levels | 3-5 weeks |
| Change in number of flavored cigars, unflavored cigars, and cigarettes smoked per day | Participants will record tobacco use daily on their mobile phones using an app. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Mead-Morse, PhD,MHS | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Farmington | Connecticut | 06030 | United States |
A verified database will be available once the main findings from the final dataset have been reported and accepted for publication. Information that does result from our analysis of the saliva samples will be available after publication of the findings. De-identified dataset will contain the data merged from all study visits. We will include with the data file proper documentation of all data (including definitions of variables and derived variables, frequencies, details about codes, etc.), and procedures used to collect the data, to ensure others can use the dataset and to prevent misuse, misinterpretation, and/or confusion. The database intended for public distribution will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.
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In the final year of the Award after the dataset is finalized we will prepare a file in Excel and Stata that contains all study variables intended for use in presentations and publications.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 11, 2026 | |
| Reset | Mar 30, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 11, 2026 | Mar 30, 2026 |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D000073863 | Cigar Smoking |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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Randomized cross-over study
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| Unflavored filtered cigars | Other | Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase |
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| 3-5 weeks |
| D000073869 |
| Tobacco Smoking |
| D064424 | Tobacco Use |