Acute Effects of Vaping Nicotine on Cognition in Young Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-05

Study Completion Date

2022-08-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Varenicline on Reward Responses and Cognition in Adolescent Smokers

NCT01624428

Tobacco Use Disorders

COMPLETED PHASE1

E-cigarette Nicotine Study

NCT04709471

Nicotine Dependence Electronic Cigarette Use Cigarette Smoking

COMPLETED PHASE2

Electronic Cigarettes and Reactivity to Smoking Cues

NCT01782599

Nicotine Dependence

RECRUITING NA

Understanding Factors That Influence Electronic Cigarette Nicotine Delivery Through PET Imaging of Beta-2 Nicotinic Acetylcholine Receptors

NCT04258852

Electronic Cigarette Use

WITHDRAWN NA

A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers

NCT03596034

Tobacco Use Nicotine Dependence, Other Tobacco Product Tobacco Smoking

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nicotine Addiction Vaping

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Users of Juul

Individuals who use Juul devices to vape nicotine

Group Type ACTIVE_COMPARATOR

Nicotine pod

Intervention Type DRUG

Nicotine pods administered to individuals who use Juul

Placebo pod

Intervention Type DRUG

Nicotine-free pods administered to individuals who use Juul

Controls

Healthy non-smokers

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nicotine pod

Nicotine pods administered to individuals who use Juul

Intervention Type DRUG

Placebo pod

Nicotine-free pods administered to individuals who use Juul

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes