Comparative Abuse Liability Among African American and White Smokers
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-cigarette and Heat not burn
Sponsored by
About this trial
This is an interventional other trial for Tobacco Use Disorder
Eligibility Criteria
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 HNB 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 HNB products >5x in lifetime
- use of HNB 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
E-Cigarette then Heat not burn.
Heat not burn then E-Cigarette
Arm Description
We will use a 1:1 fashion randomization to product order (combustible cigarette, e-cigarette, heat-not-burn device.
We will use a 1:1 fashion randomization to product order combustible cigarette, heat-not-burn device, e-cigarette.
Outcomes
Primary Outcome Measures
Nicotine Delivery
Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes
Secondary Outcome Measures
Full Information
NCT ID
NCT04646668
First Posted
November 9, 2020
Last Updated
July 26, 2023
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04646668
Brief Title
Comparative Abuse Liability Among African American and White Smokers
Official Title
Comparative Abuse Liability of Cigarettes, E-cigarettes, and Heat-not-burn Devices Among African American and White Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
August 26, 2021 (Actual)
Study Completion Date
August 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
20 eligible African American and white smokers will be randomized. A 1:1 randomization to product order (combustible cigarette, e-cigarette, heat-not-burn vs. combustible cigarette, heat-not-burn, e-cigarette). Randomization will be determined by computer-generated random numbers. Randomization assignments will be placed in sealed envelopes with sequential study identification numbers. After baseline data collection has been completed, the research assistant will select the sequential study identification number to determine the randomization assignment
No blinding is involved.
Due to the pilot nature of the current study, formal power calculations were not conducted. ANOVAs will be conducted to detect within-subject differences between products. A Bonferroni correction will be applied to adjust for multiple comparisons.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E-Cigarette then Heat not burn.
Arm Type
Active Comparator
Arm Description
We will use a 1:1 fashion randomization to product order (combustible cigarette, e-cigarette, heat-not-burn device.
Arm Title
Heat not burn then E-Cigarette
Arm Type
Active Comparator
Arm Description
We will use a 1:1 fashion randomization to product order combustible cigarette, heat-not-burn device, e-cigarette.
Intervention Type
Combination Product
Intervention Name(s)
E-cigarette and Heat not burn
Intervention Description
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).
Primary Outcome Measure Information:
Title
Nicotine Delivery
Description
Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes
Time Frame
Baseline, after 10 puff bout of product at 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleanor Leavens, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparative Abuse Liability Among African American and White Smokers
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