Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases

Tobacco Use Clinical Trial

Official title:

Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03612349
• Other study ID #: 1708001884
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: February 2020

Study information

• Verified date: September 2018
• Source: Brown University
• Contact: Rachel Denlinger, MPH
• Phone: 401-262-0316
• Email: rachel_denlinger[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2020
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Tobacco Use

Intervention

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

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.