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Completed

NCT Number: NCT04646668

Comparative Abuse Liability Among African American and White Smokers

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-cigarette and Heat not burn

Combination Product

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 outcomes

  1. Nicotine Delivery

    Time frame: Baseline, after 10 puff bout of product at 5 minutes

    Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 30, 2020
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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