Tobacco Use DisorderNCT04487470
Impact of Cigar Flavor in Dual Users
A study testing Flavored filtered cigars and Unflavored filtered cigars in people with Tobacco Use Disorder, run by UConn Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Flavored filtered cigars and Unflavored filtered cigars
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2020to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current regular dual uses of filtered cigars and cigarillos (FCs) and cigarettes defined as; (a) report smoking cigarettes at least weekly in the past 30 days, (b) report smoking unaltered FC (without marijuana) at least weekly in the past 30 days; and (c)report cigarette and cigar use at their current rate (or more frequently) for ≥ 3 months.
- Able to read, speak, and understand English
- Age 21-34 years
- Stable residence (does not intend to move during the study period)
- Not intending to quit smoking during the study period
- Has a smart phone with a data plan (this study is being done remotely)
- Saliva cotinine level >30 ng/mL
Who cannot join
- Self-reported current pregnancy, currently trying to become pregnant, or breast-feeding
- Current use of nicotine replacement products or cessation products (e.g., bupropion) or plans to use in the next 3 weeks for the purposes of cessation.
- Diagnosed with or being treated for COPD, emphysema, and/or uncontrolled asthma as determined by research screening.
- Currently taking anti-hypertensive medications
- Currently has pneumonia, bronchitis, or COVID symptoms that has not yet resolved, or was hospitalized or visited the ER in the past 4 weeks for a respiratory-related illness that has not yet resolved (can be re-screened once resolved)
- Resident of Alaska, Hawaii, or Massachusetts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Cigar Flavor on Tobacco Use Behaviors and Addiction in Dual Users
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:
- take about 3-4 hours of your time per week over 3-5 weeks.
- be conducted remotely by phone, video call, email, and mail.
- require a smart phone to answer 5 quick surveys a day
- you will need to answer 4 weekly surveys
- take part in a weekly video or phone call with research staff
- supply three saliva samples to be later tested for nicotine and other toxicants
- and use a device to measure your carbon monoxide levels four times a day.
You will be compensated for your time.
Read the detailed description
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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Flavored filtered cigars, Unflavored filtered cigars
- Keywords
- Dual Tobacco Use, Smoking, Cigar Smoking, Cigarette Smoking
- Medical subject headings
- Tobacco Use Disorder, Smoking, Cigar Smoking, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavored filtered cigarsOther
Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase
Unflavored filtered cigarsOther
Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Flavored filtered cigars |
| 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. Receives: Other: Unflavored filtered cigars |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3-5 weeks
Secondary outcomes (1)
Change in exhaled breath carbon monoxide (CO) level
Daily exhaled breath CO measured over the course of the study period
Measured: 3-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start24 Jun 2020
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross-over study
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Erin Mead-Morse, UConn Health
- Investigators
- Erin Mead-Morse, PhD,MHS, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487470
- Sponsor's protocol ID
- 19-202-2
- Other IDs
- K01DA048494
- Status last verified
- Oct 2025
- First submitted
- 14 Jul 2020
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cigar Flavor on Tobacco Use Behaviors and Addiction in Dual Users
- ClinicalTrials.gov ID
- NCT04487470
- Acronym / sponsor ID
- 19-202-2
- Conditions
- Tobacco Use Disorder
- Keywords
- Dual Tobacco Use, Smoking, Cigar Smoking, Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- take about 3-4 hours of your time per week over 3-5 weeks.
- be conducted remotely by phone, video call, email, and mail.
- require a smart phone to answer 5 quick surveys a day
- you will need to answer 4 weekly surveys
- take part in a weekly video or phone call with research staff
- supply three saliva samples to be later tested for nicotine and other toxicants
- and use a device to measure your carbon monoxide levels four times a day.
You will be compensated for your time.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cross-over study
| Arm | Type | Receives |
|---|---|---|
| Flavored Filtered Cigars | Experimental | Other: Flavored filtered cigarsHalf 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. |
| Unflavored Filtered Cigars | Experimental | Other: Unflavored filtered cigarsHalf 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. |
Who may qualify
- Ages
- 21 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Current regular dual uses of filtered cigars and cigarillos (FCs) and cigarettes defined as; (a) report smoking cigarettes at least weekly in the past 30 days, (b) report smoking unaltered FC (without marijuana) at least weekly in the past 30 days; and (c)report cigarette and cigar use at their current rate (or more frequently) for ≥ 3 months.
- Able to read, speak, and understand English
- Age 21-34 years
- Stable residence (does not intend to move during the study period)
- Not intending to quit smoking during the study period
Key exclusion criteria (6 listed)
- Self-reported current pregnancy, currently trying to become pregnant, or breast-feeding
- Current use of nicotine replacement products or cessation products (e.g., bupropion) or plans to use in the next 3 weeks for the purposes of cessation.
- Diagnosed with or being treated for COPD, emphysema, and/or uncontrolled asthma as determined by research screening.
- Currently taking anti-hypertensive medications
- Currently has pneumonia, bronchitis, or COVID symptoms that has not yet resolved, or was hospitalized or visited the ER in the past 4 weeks for a respiratory-related illness that has not yet resolved (can be re-screened once resolved)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavored filtered cigarsFlavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase | Other | Flavored Filtered Cigars |
| Unflavored filtered cigarsFlavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase | Other | Unflavored Filtered Cigars |
Primary outcome
Change in demand elasticity for preferred flavored filtered cigars
Time frame: 3-5 weeks
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.
Change in demand elasticity for preferred unflavored filtered cigars
Time frame: 3-5 weeks
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.
Change in cross price elasticity for filtered cigars and cigarettes
Time frame: 3-5 weeks
It is measured by the Cross-Price Purchase Task. It is the hypothetical consumption of flavored and unflavored filtered cigars as cigarette prices increase.
1 secondary outcome
Change in exhaled breath carbon monoxide (CO) level
Time frame: 3-5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Mead-Morse, PhD,MHS principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavored filtered cigars and Unflavored filtered cigars in people with Tobacco Use Disorder, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in demand elasticity for preferred flavored filtered cigars (time frame: 3-5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.