Comparative Abuse Liability Among African American and White Smokers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Tobacco Use Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: 20 eligible AA and white smokers will be randomized. We will use a 1:1 fashion randomization to product order (combustible cigarette, e-cigarette, heat-not-burn device vs. combustible cigarette, heat-not-burn device, e-cigarette). Randomization will be determined by computer-generated random numbers. Randomization assignments will be placed in sealed envelopes with sequential study ID numbers. After baseline data collection has been completed, the research assistant will select the sequential study ID number to determine the randomization assignment No blinding is involved. Due to the pilot nature of the current study, a primary aim of the study is to collect data for power calculations for a fully powered trial. Therefore, formal power calculations were not conducted. ANOVAs will be conducted to detect within-subject differences between products for all outcomes. A Bonferroni correction will be applied to adjust for multiple comparisons. Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
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 c...
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 HNB 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.
Tracking Information
- NCT #
- NCT04646668
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Eleanor Leavens, PhD University of Kansas Medical Center
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