Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases

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.

Study Overview

• Status: Unknown
• Conditions: Tobacco Use; Cigarette Smoking
• Intervention / Treatment: Behavioral: Experimental Tobacco Marketplace Task

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Denlinger, MPH; Phone Number: 401-262-0316; Email: rachel_denlinger@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Brown University School of Public Health
      • Contact: Rachel Denlinger, MPH
      • Principal Investigator: Rachel Denlinger, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of combusted tobacco purchased in mg of nicotine.	How much combusted tobacco is purchased by the participants.	through study completion, an average of 2-weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brown University
• Investigators: Principal Investigator: Rachel Denlinger, MPH, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: smoking; cigarettes
• Additional Relevant MeSH Terms: Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: 1708001884

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No