Acute Effects of Vaping Nicotine on Cognition in Young Adults

NCT04901208 | Completed

• 3 other identifiers: 20000250752UL1TR001863-061K01DA042937-01A1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Addiction; Vaping

Keywords

vaping; nicotine; juul; inhibitory control; reward processing

Outcome Measures

Primary Outcomes (2)

• Neural correlates of reward

  FMRI measures of brain activation in response to reward

  Activation during study session

• Neural correlates of executive function

  FMRI measures of brain activation in response to tasks

  activation during study session

Study Arms (2)

Users of Juul

ACTIVE COMPARATOR

Individuals who use Juul devices to vape nicotine

Drug: Nicotine pod; Drug: Placebo pod

Controls

NO INTERVENTION

Healthy non-smokers

Interventions

Nicotine pod DRUG

Nicotine pods administered to individuals who use Juul

Users of Juul

Placebo pod DRUG

Nicotine-free pods administered to individuals who use Juul

Users of Juul

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to provide written informed consent and to comply with all study procedures.
• For Juul users, Healthy adults between 18-30 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 18-30 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.

You may not qualify if:

• A serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain.
• A medical condition that requires treatment with a medication with psychotropic effects.
• Occurrence of a stroke, as reported by the participant during screening.
• Any contraindications to MRI scanning (i.e., metal implants, pacemakers, etc.)
• History of loss of consciousness (LOC) for longer than 30 minutes or LOC with any neurological sequelae.
• DSM-5 criteria for intellectual disability.
• 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.
• Pregnancy, as indicated by initial screening or verbal confirmation of pregnancy at one of the four testing sessions.
• (Controls only) any reports or indications (via cotinine testing) of nicotine use.
• 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.
• 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.
• Medical conditions increasing risk of respiratory problems in nonpatient populations: Chronic Pulmonary Conditions;
• Untreated, unresolved, acute pulmonary conditions (recurring bronchitis and Reactive airway disorder, as examples)
• Known hypersensitivity to propylene glycol.
• Planning to quit smoking with a set goal or time for quit attempt

Sponsors & Collaborators

• Yale University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Study Officials

• Kristen P Morie, PHD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 25, 2021
• Study Start: April 5, 2020
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

US (1)