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Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases

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ClinicalTrials.gov Identifier: NCT03612349
Recruitment Status : Unknown
Verified September 2018 by Brown University.
Recruitment status was:  Recruiting
First Posted : August 2, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Brown University

Brief 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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cigarette Smoking Behavioral: Experimental Tobacco Marketplace Task Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Masking Description: There is no masking since participants experience both marketplace conditions.
Primary Purpose: Other
Official Title: Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arm Intervention/treatment
Condition 1: All Products
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.
Behavioral: Experimental Tobacco Marketplace Task
Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.
Other Names:
  • Condition 1: All Products
  • Condition 2: No menthol LCCs

Condition 2: No menthol LCCs
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.
Behavioral: Experimental Tobacco Marketplace Task
Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.
Other Names:
  • Condition 1: All Products
  • Condition 2: No menthol LCCs




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Tobacco Product Demand Curves [ Time Frame: through study completion, an average of 2-weeks. ]
    Purchasing data will be used to generate demand curves for each tobacco product available on the online tobacco marketplace.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ages 18 and older
  2. Daily smokers who smoke on average at least 5 cigarettes per day for the past 12 months
  3. Self-report smoking a menthol cigarette brand
  4. Must report use of an alternative tobacco product(s) at least once in the past month
  5. Breath CO levels > 8 ppm (if < 8 ppm, then NicAlert Strip = 6)
  6. Speak, comprehend, and read English well enough to complete study procedures

Exclusion Criteria:

  1. Breath alcohol level > 0.01 ng/ml
  2. Intention to quit smoking in the next 30 days
  3. Self-reported serious medical or psychiatric conditions during the past 12 months including:

    1. heart attack
    2. stroke
    3. angina
    4. blood clots in the arms or legs for which the individual is undergoing active medical treatment
    5. cancer requiring active chemotherapy or radiation therapy
    6. chronic obstructive pulmonary disease
    7. schizophrenia
  4. Pregnant or breastfeeding
  5. CO reading > 80 ppm
  6. Enrollment stratum (white or African-American/black) is full

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612349


Contacts
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Contact: Rachel Denlinger, MPH 401-262-0316 rachel_denlinger@brown.edu

Locations
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United States, Rhode Island
Brown University School of Public Health Recruiting
Providence, Rhode Island, United States, 02903
Contact: Rachel Denlinger, MPH         
Principal Investigator: Rachel Denlinger, MPH         
Sponsors and Collaborators
Brown University
Investigators
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Principal Investigator: Rachel Denlinger, MPH Brown University
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03612349    
Other Study ID Numbers: 1708001884
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brown University:
cigarettes
smoking
Additional relevant MeSH terms:
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Menthol
Antipruritics
Dermatologic Agents