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



Status:Recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 99
Updated:3/21/2019
Start Date:November 12, 2018
End Date:May 31, 2019
Contact:Theodore Wagener, PhD
Email:theodore-wagener@ouhsc.edu
Phone:405-271-8001

Use our guide to learn which trials are right for you!

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 20 current cigarette users (n=10) and dual e-cigarette
and combustible cigarette users (n=10) 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.

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.

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.

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,

- 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.
We found this trial at
1
site
655 Research Parkway
Oklahoma City, Oklahoma 73104
Phone: 405-271-8001
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials