Comparative Abuse Liability Among African American and White Smokers
- Conditions
- Tobacco Use Disorder
- Interventions
- Combination Product: E-cigarette and Heat not burn
- Registration Number
- NCT04646668
- Lead Sponsor
- University of Kansas Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description E-Cigarette then Heat not burn. E-cigarette and Heat not burn We will use a 1:1 fashion randomization to product order (combustible cigarette, e-cigarette, heat-not-burn device. Heat not burn then E-Cigarette E-cigarette and Heat not burn We will use a 1:1 fashion randomization to product order combustible cigarette, heat-not-burn device, e-cigarette.
- Primary Outcome Measures
Name Time Method Nicotine Delivery Baseline, after 10 puff bout of product at 5 minutes Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Missouri, United States