Clinical trial NCT04646668: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1. 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
2. No blinding is involved.
3. 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Nicotine Delivery
timeFrame: Baseline, after 10 puff bout of product at 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Eleanor Leavens, PhD
role: PRINCIPAL_INVESTIGATOR
References: