Baby Albert: Electronic Cigarette Pharmacokinetics (PK) and Abuse Liability

The overall aim of the current research is to understand purchasing and product choice behaviors of tobacco/nicotine users if banning the sale of fully nicotinized cigarettes were to go into effect. A sample of up to 30 current cigarette users (n=15) and dual e-cigarette and combustible cigarette users (n=15) who are willing to try an alternative nicotine-delivery device will be recruited. They will complete the screening visit, visit 1 and 2 preceded by 12 hours of nicotine/tobacco abstinent.

Study Overview

• Status: Completed
• Conditions: Tobacco Use

Detailed Description

Participants will be provided information about the study and will provide initial consent for screening via an online screener. Written consent will be completed in person when participants are present to the laboratory. Eligible participants will include anyone over the age of 18 years and those who exclusively use combustible cigarettes or those who dual use e-cigarettes and combustible cigarettes. For the exclusive cigarette group, we will allow some e-cigarette experimentation. Participants will complete three in-lab study visits (1 screener visit and 2 study visits) separated by a standard minimum 48-hour washout period. They will be offered an Uber or other rideshare service as transportation to each study visit, however, they will not be required to use the service.

Participants will complete an in-person screening visit in which they will be rescreened according to the eligibility criteria. Their exhaled carbon monoxide (eCO) will be checked prior to their visits as well as breath alcohol and urine pregnancy (for females) test will be conducted. Participant will also complete baseline assessment measures and Balloon Analog Risk Task (BART)- computerized task measuring impulsivity. At visit 2, participants will complete a standard 10 puff bout with the three e-cigarette devices and their usual brand cigarette. During visit 3, participants will complete three concurrent choice tasks in a counter-balanced fashion.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center Tobacco Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A sample of up to 30 current cigarette smokers and dual e-cigarette and cigarette users 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.

Description

Inclusion Criteria:

• 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
• should have healthy veins

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

Exclusion Criteria:

• 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
• history of cardiac event or distress within the past 3 months
• currently suffering from any blood disorder that includes von willebrand, hemophilia, anemia, sickle cell, leukopenia, thrombocytopenia
• currently taking an anticoagulant or blood thinning medications
• have stent, graph, mastectomy or artificial hardware placed in arms or hands (bilaterally)

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Nicotine delivery measured by serum (blood) nicotine	Participants will complete one standardized puffing bout (10 puffs) with each of the three electronic cigarettes and their usual brand cigarette. Serum nicotine will be measured throughout each standardized puffing bout. Greater levels of serum nicotine will be indicative of greater nicotine delivery.	1 month

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Theodore Wagener, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): May 23, 2019
• Study Completion (Actual): May 23, 2019

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: e-cigarettes; juul brand e-cigarette; njoy brand e-cigarette; evolv/mirage DNA 75c brand e-cigarette
• Other Study ID Numbers: 8988

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No