Overview

Acute Effects of Vaping Nicotine on Cognition in Young Adults

Status:
Recruiting
Trial end date:
2023-04-05
Target enrollment:
0
Participant gender:
All
Summary
To examine reward processing and cognitive control both with and without the influence of vaporized nicotine in young adults with no history of cigarette use using EEG and fMRI. The goal is to determine whether acute nicotine administration using a Juul device would impact functional correlates of reward and inhibitory control in people who commonly use juul devices.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Yale University
Treatments:
Nicotine
Criteria
Inclusion Criteria:

- Ability to provide written informed consent and to comply with all study procedures.

For Juul users, Healthy adults between 18-3025 years of age who are users of Juul (defined
as reporting Juul use of 5% nicotine pods 3x per week or more and not active or previous
users of cigarettes. If the first testing day reveals no cotinine in a self-reported Juul
user, participants will not be permitted to continue in the study. Vaping naïve will also
be defined as vaping for less than 3 months or less than 12 times. This is to prevent
nicotine-naïve individuals from trying to participate for study compensation.

Juul users will be required to already own a Juul device at screening (ie: not naive), to
preclude any individuals from potentially purchasing a Juul device to join in the study.
However, individuals who are 18-20 will not bring their device to the laboratory, and will
instead be provided a Juul device to use.

Controls will be healthy adults between 18-3025 years of age with no history of any
nicotine use. Controls will not vape during the study at any time or have any exposure to
e-cigarettes.

Exclusion Criteria:

- 1. A serious neurological or endocrine disorder or any medical condition or treatment
known to affect the brain.

2. A medical condition that requires treatment with a medication with psychotropic
effects.

3. Occurrence of a stroke, as reported by the participant during screening. 4. Any
contraindications to MRI scanning (i.e., metal implants, pacemakers, etc.) 5. History
of loss of consciousness (LOC) for longer than 30 minutes or LOC with any neurological
sequelae.

6. DSM-5 criteria for intellectual disability. 7. Current or a history of active
neurological or psychiatric disorders, such as psychosis, bipolar illness, major
depression, organic brain disease, dementia or DSM-V Axis I Psychiatric Disorder,
including current alcohol or substance disorders.

8. Pregnancy, as indicated by initial screening or verbal confirmation of pregnancy at
one of the four testing sessions.

9. (Controls only) any reports or indications (via cotinine testing) of nicotine use.

10. Use of cannabis products use of CBD/THC or marijuana related products. THC testing
is required at baseline and before each exposure to e-cigarettes and will exclude
administration of e-cigarettes if positive. In addition, subjects who have vaped
tetrahydrocannabinol (THC), cannabis (oil, dabs), or modified products with substances
added that were not intended by the manufacturer, or any vaped consumables acquired
from a street vendor, friend/acquaintance, or other informal source in the 90 days
prior to enrollment.

11. Any significant current medical condition such as neurological, cardiovascular,
endocrine, renal, or hepatic pathology that would increase risk or would interfere
with/mimic tobacco abstinence.

b. Medical conditions increasing risk of respiratory problems in nonpatient
populations: Chronic Pulmonary Conditions; c. Untreated, unresolved, acute pulmonary
conditions (recurring bronchitis and Reactive airway disorder, as examples) 12. Known
hypersensitivity to propylene glycol. 13. Planning to quit smoking with a set goal or
time for quit attempt