Tobacco UseNCT03612349
Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases
A study testing Experimental Tobacco Marketplace Task in people with Tobacco Use and Cigarette Smoking, run by Brown University at 1 site in United States.
Trial summary
In this study, participants will complete a behavioral economics laboratory task and validation field assessments to understand how menthol cigarette policy restrictions may affect tobacco product purchasing and use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Cigarette Smoking
- What is being tested?
- Experimental Tobacco Marketplace Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2018to Feb 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 and older
- Daily smokers who smoke on average at least 5 cigarettes per day for the past 12 months
- Self-report smoking a menthol cigarette brand
- Must report use of an alternative tobacco product(s) at least once in the past month
- Breath CO levels > 8 ppm (if < 8 ppm, then NicAlert Strip = 6)
- Speak, comprehend, and read English well enough to complete study procedures
Who cannot join
- Breath alcohol level > 0.01 ng/ml
- Intention to quit smoking in the next 30 days
- Self-reported serious medical or psychiatric conditions during the past 12 months including:
- heart attack
- stroke
- angina
Show all 13Show fewer
- blood clots in the arms or legs for which the individual is undergoing active medical treatment
- cancer requiring active chemotherapy or radiation therapy
- chronic obstructive pulmonary disease
- schizophrenia
- Pregnant or breastfeeding
- CO reading > 80 ppm
- Enrollment stratum (white or African-American/black) is full
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brown University School of Public Health
Providence, Rhode Island, 02903
Rachel Denlinger, MPH
Rachel Denlinger, MPH
About this study
In this study, participants will complete a behavioral economics laboratory task and validation field assessments to understand how menthol cigarette policy restrictions may affect tobacco product purchasing and use.
Read the detailed description
We will enroll 60 smokers who will complete four lab sessions and two field assessments. Participants meeting initial eligibility criteria over the phone will complete an in-person screening visit. Breath carbon monoxide and alcohol tests will be collected. Participants will answer questionnaires on the computer and via interview about their tobacco use and medical history. Eligible participants will remain in the lab to complete additional baseline questionnaires and will be given the opportunity to sample alternative tobacco products, such as LCCs, smokeless tobacco, electronic cigarettes, and nicotine replacement.
During the next two lab sessions, participants will complete a behavioral economics assessment, the Experimental Tobacco Marketplace task, designed to simulate purchasing tobacco products online. Participants will be given 'coupons' to obtain tobacco products from the online experimental marketplace. After these lab sessions, participants will be provided with the tobacco products they selected from the online experimental marketplace to use during 3-day field assessments to validate the task. Participants will be told to only use tobacco products provided by the lab during the field assessments. At both lab sessions, participants will complete questionnaires about their tobacco use, mood, and reactions to the alternative tobacco products. At the final lab session, a qualitative interview will be conducted to learn more about the participants' experiences selecting and using tobacco products.
- Conditions
- Tobacco Use, Cigarette Smoking
- Being tested
- Experimental Tobacco Marketplace Task
- Keywords
- cigarettes, smoking
- Medical subject headings
- Tobacco Use, Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Tobacco Marketplace TaskBehavioural
Also called Condition 1: All Products, Condition 2: No menthol LCCs
Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: All Products | Other | Experimental Tobacco Marketplace Task is a behavioral economics task. During the task, participants purchase products from an online tobacco marketplace. In this condition, all tobacco products are available in menthol and non-menthol flavors. Receives: Behavioral: Experimental Tobacco Marketplace Task |
| Condition 2: No menthol LCCs | Other | Experimental Tobacco Marketplace Task is a behavioral economics task. During the task, participants purchase products from an online tobacco marketplace. In this condition, the online tobacco marketplace does not include menthol flavored little cigars and cigarillos. Receives: Behavioral: Experimental Tobacco Marketplace Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of combusted tobacco purchased in mg of nicotine.
How much combusted tobacco is purchased by the participants.
Measured: through study completion, an average of 2-weeks.
Secondary outcomes (1)
Tobacco Product Demand Curves
Purchasing data will be used to generate demand curves for each tobacco product available on the online tobacco marketplace.
Measured: through study completion, an average of 2-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start9 Jul 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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
- Participants will complete the Experimental Tobacco Marketplace Task under two marketplace conditions. One condition has all tobacco products available in menthol and non-menthol flavors. The other condition does not include alternative flavored combusted products.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Denlinger, MPH, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612349
- Sponsor's protocol ID
- 1708001884
- Status last verified
- Sep 2018
- First submitted
- 26 Jul 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases
- ClinicalTrials.gov ID
- NCT03612349
- Acronym / sponsor ID
- 1708001884
- Conditions
- Tobacco Use, Cigarette Smoking
- Keywords
- cigarettes, smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 2 Aug 2018 (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.
In this study, participants will complete a behavioral economics laboratory task and validation field assessments to understand how menthol cigarette policy restrictions may affect tobacco product purchasing and use.
Detailed description
We will enroll 60 smokers who will complete four lab sessions and two field assessments. Participants meeting initial eligibility criteria over the phone will complete an in-person screening visit. Breath carbon monoxide and alcohol tests will be collected. Participants will answer questionnaires on the computer and via interview about their tobacco use and medical history. Eligible participants will remain in the lab to complete additional baseline questionnaires and will be given the opportunity to sample alternative tobacco products, such as LCCs, smokeless tobacco, electronic cigarettes, and nicotine replacement.
During the next two lab sessions, participants will complete a behavioral economics assessment, the Experimental Tobacco Marketplace task, designed to simulate purchasing tobacco products online. Participants will be given 'coupons' to obtain tobacco products from the online experimental marketplace. After these lab sessions, participants will be provided with the tobacco products they selected from the online experimental marketplace to use during 3-day field assessments to validate the task. Participants will be told to only use tobacco products provided by the lab during the field assessments. At both lab sessions, participants will complete questionnaires about their tobacco use, mood, and reactions to the alternative tobacco products. At the final lab session, a qualitative interview will be conducted to learn more about the participants' experiences selecting and using tobacco products.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete the Experimental Tobacco Marketplace Task under two marketplace conditions. One condition has all tobacco products available in menthol and non-menthol flavors. The other condition does not include alternative flavored combusted products.
| Arm | Type | Receives |
|---|---|---|
| Condition 1: All Products | Other | Behavioral: Experimental Tobacco Marketplace TaskExperimental Tobacco Marketplace Task is a behavioral economics task. During the task, participants purchase products from an online tobacco marketplace. In this condition, all tobacco products are available in menthol and non-menthol flavors. |
| Condition 2: No menthol LCCs | Other | Behavioral: Experimental Tobacco Marketplace TaskExperimental Tobacco Marketplace Task is a behavioral economics task. During the task, participants purchase products from an online tobacco marketplace. In this condition, the online tobacco marketplace does not include menthol flavored little cigars and cigarillos. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18 and older
- Daily smokers who smoke on average at least 5 cigarettes per day for the past 12 months
- Self-report smoking a menthol cigarette brand
- Must report use of an alternative tobacco product(s) at least once in the past month
- Breath CO levels > 8 ppm (if < 8 ppm, then NicAlert Strip = 6)
Key exclusion criteria (13 listed)
- Breath alcohol level > 0.01 ng/ml
- Intention to quit smoking in the next 30 days
- Self-reported serious medical or psychiatric conditions during the past 12 months including:
- Pregnant or breastfeeding
- CO reading > 80 ppm
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 |
|---|---|---|
| Experimental Tobacco Marketplace TaskAlso: Condition 1: All Products, Condition 2: No menthol LCCsParticipants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions. | Behavioural | Condition 1: All Products, Condition 2: No menthol LCCs |
Primary outcome
Total amount of combusted tobacco purchased in mg of nicotine.
Time frame: through study completion, an average of 2-weeks.
How much combusted tobacco is purchased by the participants.
1 secondary outcome
Tobacco Product Demand Curves
Time frame: through study completion, an average of 2-weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Rachel Denlinger, MPH principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Tobacco Marketplace Task in people with Tobacco Use and Cigarette Smoking, run by Brown University 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 13 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: status not confirmed, as of the sponsor's last update on 28 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Denlinger, MPH (401-262-0316, rachel_denlinger@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of combusted tobacco purchased in mg of nicotine. (time frame: through study completion, an average of 2-weeks.). 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 28 Sep 2018.