Comparative Abuse Liability Among African American and White Smokers

University of Kansas

Status

Completed

Conditions

Tobacco Use Disorder

Treatments

Combination Product: E-cigarette and Heat not burn

Study type

Interventional

Funder types

Other

Identifiers

NCT04646668

00145421

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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