Clinical trial NCT03612349: Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases
Official title: Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Use
Cigarette Smoking
Keywords: cigarettes
smoking
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Total amount of combusted tobacco purchased in mg of nicotine.
timeFrame: through study completion, an average of 2-weeks.
Secondary outcomes:
measure: Tobacco Product Demand Curves
timeFrame: through study completion, an average of 2-weeks.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University
name: Rachel Denlinger, MPH
role: PRINCIPAL_INVESTIGATOR
References: