Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases

NCT ID: NCT03612349

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-09
• Study Completion Date: 2020-02-29

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.

Conditions

Tobacco Use; Cigarette Smoking

Keywords

cigarettes; smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Experimental Tobacco Marketplace Task

Intervention Type: BEHAVIORAL

Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.

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.

Group Type: OTHER

Experimental Tobacco Marketplace Task

Intervention Type: BEHAVIORAL

Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.

Interventions

Experimental Tobacco Marketplace Task

Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.

Intervention Type: BEHAVIORAL

Other Intervention Names

Condition 1: All Products; Condition 2: No menthol LCCs

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Denlinger, MPH

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University School of Public Health

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Denlinger, MPH

Role: CONTACT

Phone: 401-262-0316

Email: rachel_denlinger@brown.edu

Facility Contacts

Rachel Denlinger, MPH

Role: primary

Other Identifiers

1708001884

Identifier Type: -

Identifier Source: org_study_id