Comparative Abuse Liability Among African American and White Smokers

Tobacco Use Disorder Clinical Trial

Official title:

Comparative Abuse Liability of Cigarettes, E-cigarettes, and Heat-not-burn Devices Among African American and White Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646668
• Other study ID #: 00145421
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: August 26, 2021

Study information

• Verified date: July 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a randomized crossover trial. Current smokers will complete a session with each product: usual brand cigarette, e-cigarette, and heat-not-burn. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring.

Description:

The study is a randomized crossover trial. Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn). Throughout each visit, blood will be collected for nicotine analysis via an IV catheter placed in the patient's arm. Blood samples will be aliquoted into two separate vials. One will be analyzed for the current study and one will be placed in a biospecimen repository if participant provides consent for biorepository. Puff topography will be collected passively throughout the session to measure puffing patterns. Participants will complete self-report measures of nicotine withdrawal and craving. Finally, breath samples will be collected to measure changes in exhaled carbon monoxide, a potent lung toxicant, pre- and post-product use. At the final visit, participants will complete a behavioral economics concurrent choice task (see below for description) to behaviorally measure their decisions regarding use of e-cigarettes or heat not burn products in place of cigarettes. Finally, participants will be contacted by phone 6 months following the conclusion of visit 3 (or study discontinuation) to complete a phone survey. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring. We have no hypotheses related to the follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 26, 2021
• Est. primary completion date: August 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Non-Hispanic African American or white/Caucasian,

• =21 years old, smoke 5-30 cigarettes per day,

• daily cigarette smoker

• smoked at current rate for at least 6 months

• interested in trying e-cigarettes and heat not burn products

• not interested in or unable/unwilling to quit cigarette smoking

• willing to complete three in-person study visits

• willing to have IV catheter placed

Exclusion Criteria:

• Interested in quitting cigarettes in the next 30 days

• use of smoking cessation pharmacotherapy in the past 30 days

• use of non-cigarette tobacco products in the past 30 days

• use of e-cigarettes >5x in lifetime

• use of e-cigarettes =4 of the past 30 days

• use of heat not burn products >5x in lifetime

• use of heat not burn products =4 of the past 30 days

• weight < 110 lbs

• uncontrolled hypertension (systolic BP = 180 or diastolic BP = 105)

• pregnant, plans to become pregnant, or breastfeeding

• live >10 miles from study site (Fairway CRU)

• current enrollment is a research study or program that aims to alter tobacco use

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Combination Product:
• E-cigarette and Heat not burn
Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn).

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nicotine Delivery	Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes	Baseline, after 10 puff bout of product at 5 minutes