Acute Effects of Vaping Nicotine on Cognition in Young Adults

Acute Effects of Vaping Nicotine on Reward Processing and Inhibitory Control in Young Adults

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.

Study Overview

• Status: Completed
• Conditions: Vaping; Nicotine Addiction
• Intervention / Treatment: Drug: Nicotine pod; Drug: Placebo pod

Detailed Description

Aim 1: To examine reward processing 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 distinguishable reward processes (anticipatory and consummatory reward) in young adults who commonly use juul devices. Predictions are that juul use will have an impact on activity in the striatum, resulting in reduced activation in fMRI and smaller amplitudes in event-related potentials (ERP) in response to reward cues and reward feedback.

Aim 2: To examine 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 behavioral inhibition in young adults who commonly use juul devices. Predictions are that juul use will affect the inhibitory circuit, including the anterior cingulate and the dorso-lateral prefrontal cortex, resulting in decreased activation in these regions during fMRI and reductions in the FRN and P300 ERP responses in response to inhibitions and to commission errors. Predictions also include that inhibitory control behavior will be impaired after juul use.

Aim 3: To establish feasibility of naturalistic use of vaping devices for nicotine administration and observing the effects in the laboratory.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen P Morie, PHD; Phone Number: 9144622110; Email: kristen.morie@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Users of Juul; Individuals who use Juul devices to vape nicotine	Drug: Nicotine pod; Nicotine pods administered to individuals who use Juul; Drug: Placebo pod; Nicotine-free pods administered to individuals who use Juul
No Intervention: Controls; Healthy non-smokers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Kristen P Morie, PHD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2020
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: nicotine; vaping; juul; inhibitory control; reward processing
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2000025075; 2UL1TR001863-06 (U.S. NIH Grant/Contract); 1K01DA042937-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

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