E-Cigarette and Cigarette Nicotine Delivery and Abuse Liability in Cigarette Smokers and Dual Users

Withdrawn before enrolling

Conditions studied: Tobacco Use

In brief

The FDA has shown clear interest in strategies that will reduce the public health burden of tobacco use. One proposed strategy includes banning the sale of fully nicotinized cigarettes and only allowing VLNCs (Very Low Nicotine Cigarettes) to be sold. While there are concerns regarding the unintended consequences (e.g., black market sales of fully nicotinized cigarettes) of such bans, research is needed to understand how smokers and dual users will act in the potential market. The overall aim of the current research is to understand purchasing and product choice behaviors of tobacco/nicotine users if the proposed ban were to go into effect.

Key facts

Study ID

NCT03943706

Run by

University of Oklahoma

People needed

0

Starts

2019-06-01

Expected to finish

2019-12-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• be at least 18 years old
• live within 30 miles of the research site
• interested in/willing to use an e-cigarette during study visits
• be willing and able to complete study procedures including specimen collection, survey completion, and remaining nicotine abstinent for 12 hours prior to each study visit
• speak and understand English
• willing to provide informed consent
• bring usual brand cigarettes to screener study visit.
• Additional Inclusion criteria for smokers:
• smoke at least 10 cigarettes per day for the past three months,
• exhaled more than equal to 6 ppm carbon monoxide at the screener visit.
• Additional Inclusion criteria for dual users:
• smoke more than equal to 5 tobacco cigarettes per day for the last 3 months,
• use e-cigarettes at least 15 days per month for the last 3 months, and
• bring e-cigarette device to screener study visit.

You may not qualify if…

• currently suffering from lung disease including asthma, cystic fibrosis (CF), or chronic obstructive pulmonary disease (COPD), unless it is well-controlled,
• currently pregnant or breast-feeding or have plans to become pregnant or begin breast-feeding at any point during the study,
• intoxicated at study visits (breath alcohol testing and clean urine drug screen),
• any known allergies or sensitivity to the known major constituents contained in the aerosol of the study e-cigarette devices (e.g., flavorants, vegetable glycerin, propylene glycol),
• User of zero-nicotine e-cigarettes,
• smokes mentholated cigarettes regularly,
• history of cardiac event or distress within the past 3 months.
• Additional Exclusion criteria for smokers:
• have previously used any e-cigarette device (cig-a-like, pen style, mod, APV) for longer than 30 days
• use of an e-cigarette device over the past 14 days.

Where it is running

• University of Oklahoma Health Sciences Center Oklahoma Tobacco Research Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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