Comparative Abuse Liability Among African American and White Smokers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Combination Product: E-cigarette and Heat not burn


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E-Cigarette then Heat not burn.<br>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<br>* 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).<br>|
| Active Comparator: Heat not burn then E-Cigarette<br>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<br>* 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).<br>|

What is the study measuring?
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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 |