Comparative Abuse Liability Among African American and White Smokers

NCT04646668 | Completed Results FDA Device

• 1 other identifier: 00145421
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

E-Cigarette then Heat not burn.

ACTIVE COMPARATOR

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

Heat not burn then E-Cigarette

ACTIVE COMPARATOR

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

Interventions

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).

E-Cigarette then Heat not burn.; Heat not burn then E-Cigarette

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

Location

Related Publications (1)

• Funk OL, Nollen NL, Wagener TL, Ahluwalia JS, Mayo MS, Mahmud KMF, Lambart L, Leavens ELS. Concurrent Choice Assessment of Preference and Substitutability of E-cigarettes and Heated Tobacco Products for Combustible Cigarettes Among African American and White Smokers. Nicotine Tob Res. 2023 Jul 14;25(8):1505-1508. doi: 10.1093/ntr/ntad052.

  PMID: 37042345 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Leah Lambart Graduate Research Assistant
• Organization: University of Kansas Medical Center

llambart@kumc.edu

9139457862

Study Officials

• Eleanor Leavens, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 30, 2020
• Study Start: September 21, 2020
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: July 28, 2023
• Results First Posted: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)