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Acute Effects of Vaping Nicotine on Cognition in Young Adults

Primary Purpose

Nicotine Addiction, Vaping

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine pod
Placebo pod
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Addiction focused on measuring vaping, nicotine, juul, inhibitory control, reward processing

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Users of Juul

Controls

Arm Description

Individuals who use Juul devices to vape nicotine

Healthy non-smokers

Outcomes

Primary Outcome Measures

Neural correlates of reward
FMRI measures of brain activation in response to reward
Neural correlates of executive function
FMRI measures of brain activation in response to tasks

Secondary Outcome Measures

Full Information

First Posted
April 30, 2021
Last Updated
August 22, 2023
Sponsor
Yale University
Collaborators
National Center for Advancing Translational Sciences (NCATS), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04901208
Brief Title
Acute Effects of Vaping Nicotine on Cognition in Young Adults
Official Title
Acute Effects of Vaping Nicotine on Reward Processing and Inhibitory Control in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2020 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Center for Advancing Translational Sciences (NCATS), National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Addiction, Vaping
Keywords
vaping, nicotine, juul, inhibitory control, reward processing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Users of Juul
Arm Type
Active Comparator
Arm Description
Individuals who use Juul devices to vape nicotine
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Healthy non-smokers
Intervention Type
Drug
Intervention Name(s)
Nicotine pod
Intervention Description
Nicotine pods administered to individuals who use Juul
Intervention Type
Drug
Intervention Name(s)
Placebo pod
Intervention Description
Nicotine-free pods administered to individuals who use Juul
Primary Outcome Measure Information:
Title
Neural correlates of reward
Description
FMRI measures of brain activation in response to reward
Time Frame
Activation during study session
Title
Neural correlates of executive function
Description
FMRI measures of brain activation in response to tasks
Time Frame
activation during study session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen P Morie, PHD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

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Acute Effects of Vaping Nicotine on Cognition in Young Adults

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