Nicotine AddictionNCT04901208
Acute Effects of Vaping Nicotine on Cognition in Young Adults
A study testing Nicotine pod in people with Nicotine Addiction and Vaping, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Addiction, Vaping
- What is being tested?
- Nicotine pod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2020to 17 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nicotine Addiction, Vaping
- Being tested
- Nicotine pod, Placebo pod
- Keywords
- vaping, nicotine, juul, inhibitory control, reward processing
- Medical subject headings
- Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine podDrug
Nicotine pods administered to individuals who use Juul
Placebo podDrug
Nicotine-free pods administered to individuals who use Juul
| Study group | Role | What they receive |
|---|---|---|
| Users of Juul | Active comparator | Individuals who use Juul devices to vape nicotine Receives: Drug: Nicotine pod; Drug: Placebo pod |
| Controls | No intervention | Healthy non-smokers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural correlates of reward
FMRI measures of brain activation in response to reward
Measured: Activation during study session
Neural correlates of executive function
FMRI measures of brain activation in response to tasks
Measured: activation during study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start5 Apr 2020
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kristen P Morie, PHD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901208
- Sponsor's protocol ID
- 2000025075
- Other IDs
- 2UL1TR001863-06, 1K01DA042937-01A1
- Status last verified
- Mar 2024
- First submitted
- 30 Apr 2021
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Vaping Nicotine on Reward Processing and Inhibitory Control in Young Adults
- ClinicalTrials.gov ID
- NCT04901208
- Acronym / sponsor ID
- 2000025075
- Conditions
- Nicotine Addiction, Vaping
- Keywords
- vaping, nicotine, juul, inhibitory control, reward processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), National Institute on Drug Abuse (NIDA)
- Study start
- 5 Apr 2020 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Users of Juul | Active comparator | Drug: Nicotine pod, Drug: Placebo podIndividuals who use Juul devices to vape nicotine |
| Controls | No intervention | –Healthy non-smokers |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine podNicotine pods administered to individuals who use Juul | Drug | Users of Juul |
| Placebo podNicotine-free pods administered to individuals who use Juul | Drug | Users of Juul |
Primary outcome
Neural correlates of reward
Time frame: Activation during study session
FMRI measures of brain activation in response to reward
Neural correlates of executive function
Time frame: activation during study session
FMRI measures of brain activation in response to tasks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen P Morie, PHD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine pod in people with Nicotine Addiction and Vaping, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural correlates of reward (time frame: Activation during study session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.