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

NCT03943706 | Withdrawn DMC

• 1 other identifier: 8841
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use

Keywords

e-cigarettes; JUUL brand e-cigarette; NJOY brand e-cigarette; EVOLV brand mod e-cigarette; Very Low Nicotine Cigarettes (VLNCs)

Outcome Measures

Primary Outcomes (2)

• Nicotine delivery measured by serum (blood) nicotine

  Participants will complete one standardized puffing bout (10 puffs) with each of the three electronic cigarettes, usual brand cigarette and Very Low Nicotine Cigarettes (VLNCs). Serum nicotine will be measured throughout each standardized puffing bout. Greater levels of serum nicotine will be indicative of greater nicotine delivery.

  1 month

• Proportion of puffs earned and allocated to each product in three hypothetical tobacco regulatory scenarios

  Participants will complete three computer tasks simulating hypothetical regulatory scenarios and will earn and allocate puffs to study products. A greater proportion of puffs allocated will indicate greater demand for the product in that hypothetical scenario

  1 month

Study Arms (2)

Exclusive cigarette smokers

Exclusive cigarette smokers must smoke at least 10 cigarettes per day for the past three months and have exhaled carbon monoxide (eCO) levels of at least 6 ppm at the screening visit.

Dual (Electronic cigarette and cigarette smoking) users

Dual e-cigarette and cigarette users must have smoked at least 5 cigarettes per day for the last 3 months and use e-cigarettes at least 15 days per month for the last 3 months.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A sample of 40 current cigarette smokers (n=20) and dual e-cigarette and cigarette users (n=20) who are willing to use/try an alternative nicotine-delivery device will be recruited via advertisements/ recruitment materials (e.g., craigslist, ads on OSU, OU, and UCO campuses, OUHSC, email) and referrals. Participants will live in the Oklahoma City, OK metro area. Participants will be provided information about the study and provide initial consent for screening via an online screener.

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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center Oklahoma Tobacco Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

During their PK (Pharmacokinetics) visits, Blood will be collected during specific time points and plasma will be extracted from the blood. Plasma will be used to analyze the levels of nicotine in it. Urine will be collected from female participants in order to confirm their pregnancy status. Saliva will be collected during their screening visit to analyze for cotinine levels in order to check their smoking status.

MeSH Terms

Conditions

Tobacco Use; Vaping

Condition Hierarchy (Ancestors)

Behavior; Smoking

Study Officials

• Theodore Wagener, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

US (1)