Comparative Abuse Liability Among African American and White Smokers

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Combination product: E-cigarette and Heat not burn

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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
Active Comparator: E-Cigarette then Heat not burn.; We will use a 1:1 fashion randomization to product order (combustible cigarette, e-cigarette, heat-not-burn device.	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).
Active Comparator: Heat not burn then E-Cigarette; We will use a 1:1 fashion randomization to product order combustible cigarette, heat-not-burn device, e-cigarette.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Eleanor Leavens, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): August 26, 2021
• Study Completion (Actual): August 26, 2021

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 00145421

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: Yes
• product manufactured in and exported from the U.S.: No