Tobacco Use DisorderNCT03496077
Addictive Potential of LCCs in Dual Users
A study testing Flavored and unflavored little cigars/cigarillos (LCCs) in people with Tobacco Use Disorder and Dual Tobacco Use, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Dual Tobacco Use, Tobacco Dependence
- What is being tested?
- Flavored and unflavored little cigars/cigarillos (LCCs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addictive Potential of Little Cigars/Cigarillos in Dual Users: Effect by Flavor and Gender
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
- Being tested
- Flavored and unflavored little cigars/cigarillos (LCCs)
- Keywords
- Dual Use, Little Cigars and Cigarillos, Cigarettes, Flavored Tobacco Use, Addiction Potential
- Medical subject headings
- Tobacco Use Disorder, Smoking, Cigar Smoking, Cigarette Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavored and unflavored little cigars/cigarillos (LCCs)Other
Flavored and unflavored LCCs that are currently available for purchase
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Flavored and unflavored little cigars/cigarillos (LCCs) |
| 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. Receives: Other: Flavored and unflavored little cigars/cigarillos (LCCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post-treatment (after 7 days of being assigned to condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start28 Aug 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Mead-Morse, UConn Health
- Investigators
- Erin L Mead, PhD,MHS, Principal investigator, UConn Health, Farmington, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496077
- Sponsor's protocol ID
- 18-091-1
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2018
- Last updated
- 10 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addictive Potential of Little Cigars/Cigarillos in Dual Users: Effect by Flavor and Gender
- ClinicalTrials.gov ID
- NCT03496077
- Acronym / sponsor ID
- 18-091-1
- Conditions
- Tobacco Use Disorder, Dual Tobacco Use, Tobacco Dependence, Smoking, Smoking, Cigar, Smoking, Cigarette
- Keywords
- Dual Use, Little Cigars and Cigarillos, Cigarettes, Flavored Tobacco Use, Addiction Potential
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 10 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 LCCs | Experimental | Other: Flavored and unflavored little cigars/cigarillos (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. |
| Unflavored LCCs | Experimental | Other: Flavored and unflavored little cigars/cigarillos (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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 and unflavored little cigars/cigarillos (LCCs)Flavored and unflavored LCCs that are currently available for purchase | Other | Flavored LCCs, Unflavored LCCs |
Primary outcome
Demand Elasticity
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 L Mead, PhD,MHS principal investigator
UConn Health, Farmington, CT
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 and unflavored little cigars/cigarillos (LCCs) in people with Tobacco Use Disorder and Dual Tobacco Use, 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 6 inclusion and 5 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 10 Mar 2026. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Demand Elasticity (time frame: Post-treatment (after being assigned to use it for 7 days)). The study lists 2 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 10 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.