Vaping TeensNCT06503159
Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study
A study testing Mindfulness-based Stress Reduction (MBSR) Program and functional magnetic resonance imaging (fMRI) in people with Vaping Teens and Healthy Volunteers, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this translational bench-to-bedside study is to examine the neurobiological effects of an evidence-based technology-delivered mindfulness training (MT) program on vaping-related rsFC alterations in hippocampal networks and testing whether changes in rsFC ((Delta)rsFC) in these networks predict reduction… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaping Teens, Healthy Volunteers
- What is being tested?
- Mindfulness-based Stress Reduction (MBSR) Program and functional magnetic resonance imaging (fMRI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2025to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Non-Vaping group:
- For adolescents aged 17 and under, parental/guardian informed consent to participate in the study
- English language fluency
- Males and females; Age 13-18 enrolled in grades 9-12, or the summer after graduation.
- No MRI contraindications
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- No evidence of current psychosis, mania, or significant suicidality
- If on medication for depression, anxiety or ADHD, dose has been stable for 3 months
- No DSM-5 diagnosis of moderate or severe substance use disorder (SUD) related to a psychoactive substance, including tobacco, in the past year
- Access to necessary resources for participating in a technology-based intervention, which includes smartphone ownership for this study
- No use of nicotine more than five (5) times in their life, and none at all in the last 30 days prior to enrollment.
- Vaping group:
- For adolescents aged 17 and under, parental/guardian informed consent to participate in the study
- English language fluency
- Males and females; Age 13-18 enrolled in grades 9-12, or the summer after graduation.
- No MRI contraindications
- No evidence of current psychosis, mania, or significant suicidality
- If on medication for depression, anxiety or attention deficit hyperactivity disorder (ADHD), dose has been stable for 3 months
- No Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of moderate or severe SUD related to another psychoactive substance (other than tobacco) in the past year
- Vape a nicotine containing product at least 10 days in the past 30 days
- Access to necessary resources for participating in a technology-based intervention, which includes smartphone ownership for this study
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study based on self and or parent-report unless otherwise noted:
- Vaping or Non-Vaping Group:
- Chronic medical conditions associated with cerebral blood flow abnormalities per PI/MAI determination after review of the medical history.
- Neurological conditions that may interfere with MRI data quality per PI/MAI determination after review of the medical history.
- Neurodevelopmental disorders that are likely to significantly affect data in the judgment of the MAI/PI
- Non-penetrating traumatic brain injury with loss of consciousness > 30 minutes or significant sequelae persisting longer than two weeks or any penetrating traumatic brain injury.
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- Changing dose of psychotropic medication in past three months
- Current regular meditation or yoga practice averaging >10 min/day for >2 days per week
- Pregnancy, self-report upon protocol entry, but by urine test prior to MRI scan.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Official title: Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents
The purpose of this translational bench-to-bedside study is to examine the neurobiological effects of an evidence-based technology-delivered mindfulness training (MT) program on vaping-related rsFC alterations in hippocampal networks and testing whether changes in rsFC ((Delta)rsFC) in these networks predict reduction in tobacco vaping behaviors in adolescents. The study also aims to test the accessibility and feasibility of using this mindfulness-based stress reduction (MBSR) platform as an implementation for widespread MT in adolescents.
Read the detailed description
Study Description:
This protocol will use functional magnetic resonance imaging (fMRI) and in-person and technology-delivered mindfulness-based stress reduction (MBSR) training to elucidate neurobehavioral correlates of regular nicotine vaping in adolescents compared to non-vaping adolescents, and changes in these correlates after MBSR training. Our central hypothesis is that nicotine vaping in adolescents will be associated with impaired hippocampal connectivity with large-scale brain networks (e.g., Executive Control network (ECN), Default Mode Network (DMN), Salience Network (SN)) involved in cognitive control and emotion regulation and decreased state transitions (measured via dynamic resting state functional connectivity (rsFC)); and that MBSR training will increase hippocampal connectivity to ECN and alter time in state and state transitions in frequent vaping adolescents, with these rsFC changes predicting changes in vaping behavior.
Objectives:
Primary Objectives:
- To characterize static and dynamic rsFC of hippocampal networks in frequent nicotine vaping adolescents compared to non-vaping adolescents.
- To characterize rsFC changes in hippocampal networks following an in-person and technology-delivered MBSR training program in frequent nicotine vaping adolescents.
Secondary Objectives:
- To assess engagement with a smoking cessation app and changes in vaping behavior, emotion and cognition in the 3 months following MBSR training.
- To assess differences between vaping and non-vaping teens pre- and post-MBSR training on other measures of network connectivity.
Endpoints:
Primary Endpoints:
- (1) Seed-based rsFC between hippocampal seed regions and large-scale brain networks (DMN, ECN, SN) and dynamic rsFC measures in 40 nicotine vaping and 40 non-vaping youth.
- (2) Seed-based rsFC between hippocampal seed regions and large-scale brain networks (DMN, ECN, SN) and dynamic rsFC measures within the nicotine vaping group Pre/Post MBSR training.
Secondary Endpoint:
- Engagement with MBSR training and post-training Craving-to-Quit app and change scores for other behavioral measure (e.g. vaping, emotion regulation).
- rsFC from seeds such as dorsal anterior cingulate.
- Conditions
- Vaping Teens, Healthy Volunteers
- Being tested
- Mindfulness-based Stress Reduction (MBSR) Program, functional magnetic resonance imaging (fMRI)
- Keywords
- Natural History, Teen, Nicotine, Vape
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Stress Reduction (MBSR) ProgramBehavioural
The study intervention is a 9-week MBSR intervention once per week in-person or remotely
functional magnetic resonance imaging (fMRI)Other
One fMRI scan for the baseline group and two scans for the interventional group
| Study group | Role | What they receive |
|---|---|---|
| Baseline group: Vapers | Experimental | Adolescents ages 13-18 years old with history of nicotine vaping, who vape 4-7 days per week, complete structural and resting fMRI of the brain and some questionnaires. Receives: Other: functional magnetic resonance imaging (fMRI) |
| Baseline group: Non-vapers | Experimental | Adolescents ages 13-18 years old with no history of nicotine vaping complete structural and resting fMRI of the brain and some questionnaires. Receives: Other: functional magnetic resonance imaging (fMRI) |
| Intervention: Mindfulness-based stress reduction (MBSR) training | Experimental | Adolescents ages 13-18 years old with history of nicotine vaping, from the baseline assessment group complete a 9-week intervention once per week in-person or remote mindfulness-based stress reduction (MBSR) training followed by a post-intervention assessment and a second fMRI brain scan. Receives: Behavioral: Mindfulness-based Stress Reduction (MBSR) Program; Other: functional magnetic resonance imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brain Connectivity Network
The change in brain connectivity network from baseline (pre mindfulness-based stress reduction (MBSR) training) to post MBSR functional magnetic resonance imaging (fMRI) brain scan. Analysis will be done as change in brain network connectivity based on pre and post MBSR fMRI scan. Change = post-pre values
Measured: Baseline (pre MBSR training) and post-MBSR training (1-6 weeks after MBSR training)
Secondary outcomes (3)
Participant Self-report Change in Vaping Behaviors
Participant self-reported change in vaping behaviors will be assessed as reported change in the number of vaping puffs per day at baseline (0-3 months pre-Mindfulness-based stress reduction (MBSR) training) and post MBSR training (up to six weeks after MBSR training). Change = post -pre values
Measured: Baseline (0-3 months pre-MBSR training) & post MBSR training (up to six weeks after MBSR training)
Participant Self-report Engagement With Mindfulness-based Stress Reduction (MBSR) Training
Participant self-reported level of engagement with mindfulness-based stress reduction (MBSR) training will be assessed as percentage of days participant reports practicing MBSR training. Analysis will be done as percentage of days participants practice MBSR training.
Measured: Up to 9 weeks during the MBSR training
Participant Self-report Engagement With the Craving-to-Quit App
Participant self-reported level of engagement with the Craving-to-Quit app, which will be tracked as how much participants reported using the craving to quit app post mindfulness-based stress reduction (MBSR) training. Analysis will be done as percentage of days participants use the app.
Measured: Up to 4 months following the MBSR training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start7 May 2025
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
Why it stopped: Administrative closure (PI unavailability)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaping TeensStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Betty Jo Salmeron, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503159
- Sponsor's protocol ID
- 10001855
- Other IDs
- 001855-DA
- Status last verified
- Feb 2026
- First submitted
- 13 Jul 2024
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents
- ClinicalTrials.gov ID
- NCT06503159
- Acronym / sponsor ID
- 10001855
- Conditions
- Vaping Teens, Healthy Volunteers
- Keywords
- Natural History, Teen, Nicotine, Vape
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative closure (PI unavailability)
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 7 May 2025 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this translational bench-to-bedside study is to examine the neurobiological effects of an evidence-based technology-delivered mindfulness training (MT) program on vaping-related rsFC alterations in hippocampal networks and testing whether changes in rsFC ((Delta)rsFC) in these networks predict reduction in tobacco vaping behaviors in adolescents. The study also aims to test the accessibility and feasibility of using this mindfulness-based stress reduction (MBSR) platform as an implementation for widespread MT in adolescents.
Detailed description
Study Description:
This protocol will use functional magnetic resonance imaging (fMRI) and in-person and technology-delivered mindfulness-based stress reduction (MBSR) training to elucidate neurobehavioral correlates of regular nicotine vaping in adolescents compared to non-vaping adolescents, and changes in these correlates after MBSR training. Our central hypothesis is that nicotine vaping in adolescents will be associated with impaired hippocampal connectivity with large-scale brain networks (e.g., Executive Control network (ECN), Default Mode Network (DMN), Salience Network (SN)) involved in cognitive control and emotion regulation and decreased state transitions (measured via dynamic resting state functional connectivity (rsFC)); and that MBSR training will increase hippocampal connectivity to ECN and alter time in state and state transitions in frequent vaping adolescents, with these rsFC changes predicting changes in vaping behavior.
Objectives:
Primary Objectives:
- To characterize static and dynamic rsFC of hippocampal networks in frequent nicotine vaping adolescents compared to non-vaping adolescents.
- To characterize rsFC changes in hippocampal networks following an in-person and technology-delivered MBSR training program in frequent nicotine vaping adolescents.
Secondary Objectives:
- To assess engagement with a smoking cessation app and changes in vaping behavior, emotion and cognition in the 3 months following MBSR training.
- To assess differences between vaping and non-vaping teens pre- and post-MBSR training on other measures of network connectivity.
Endpoints:
Primary Endpoints:
- (1) Seed-based rsFC between hippocampal seed regions and large-scale brain networks (DMN, ECN, SN) and dynamic rsFC measures in 40 nicotine vaping and 40 non-vaping youth.
- (2) Seed-based rsFC between hippocampal seed regions and large-scale brain networks (DMN, ECN, SN) and dynamic rsFC measures within the nicotine vaping group Pre/Post MBSR training.
Secondary Endpoint:
- Engagement with MBSR training and post-training Craving-to-Quit app and change scores for other behavioral measure (e.g. vaping, emotion regulation).
- rsFC from seeds such as dorsal anterior cingulate.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline group: Vapers | Experimental | Other: functional magnetic resonance imaging (fMRI)Adolescents ages 13-18 years old with history of nicotine vaping, who vape 4-7 days per week, complete structural and resting fMRI of the brain and some questionnaires. |
| Baseline group: Non-vapers | Experimental | Other: functional magnetic resonance imaging (fMRI)Adolescents ages 13-18 years old with no history of nicotine vaping complete structural and resting fMRI of the brain and some questionnaires. |
| Intervention: Mindfulness-based stress reduction (MBSR) training | Experimental | Behavioral: Mindfulness-based Stress Reduction (MBSR) Program, Other: functional magnetic resonance imaging (fMRI)Adolescents ages 13-18 years old with history of nicotine vaping, from the baseline assessment group complete a 9-week intervention once per week in-person or remote mindfulness-based stress reduction (MBSR) training followed by a post-intervention assessment and a second fMRI brain scan. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- For adolescents aged 17 and under, parental/guardian informed consent to participate in the study
- English language fluency
- Males and females; Age 13-18 enrolled in grades 9-12, or the summer after graduation.
- No MRI contraindications
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study based on self and or parent-report unless otherwise noted:
- Chronic medical conditions associated with cerebral blood flow abnormalities per PI/MAI determination after review of the medical history.
- Neurological conditions that may interfere with MRI data quality per PI/MAI determination after review of the medical history.
- Neurodevelopmental disorders that are likely to significantly affect data in the judgment of the MAI/PI
- Non-penetrating traumatic brain injury with loss of consciousness > 30 minutes or significant sequelae persisting longer than two weeks or any penetrating traumatic brain injury.
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 |
|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) ProgramThe study intervention is a 9-week MBSR intervention once per week in-person or remotely | Behavioural | Intervention: Mindfulness-based stress reduction (MBSR) training |
| functional magnetic resonance imaging (fMRI)One fMRI scan for the baseline group and two scans for the interventional group | Other | Baseline group: Non-vapers, Baseline group: Vapers, Intervention: Mindfulness-based stress reduction (MBSR) training |
Primary outcome
Change in Brain Connectivity Network
Time frame: Baseline (pre MBSR training) and post-MBSR training (1-6 weeks after MBSR training)
The change in brain connectivity network from baseline (pre mindfulness-based stress reduction (MBSR) training) to post MBSR functional magnetic resonance imaging (fMRI) brain scan. Analysis will be done as change in brain network connectivity based on pre and post MBSR fMRI scan. Change = post-pre values
3 secondary outcomes
Participant Self-report Change in Vaping Behaviors
Time frame: Baseline (0-3 months pre-MBSR training) & post MBSR training (up to six weeks after MBSR training)
Participant Self-report Engagement With Mindfulness-based Stress Reduction (MBSR) Training
Time frame: Up to 9 weeks during the MBSR training
Participant Self-report Engagement With the Craving-to-Quit App
Time frame: Up to 4 months following the MBSR training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Betty Jo Salmeron, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Stress Reduction (MBSR) Program and functional magnetic resonance imaging (fMRI) in people with Vaping Teens and Healthy Volunteers, run by National Institute on Drug Abuse (NIDA) 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 21 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 Feb 2026. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Brain Connectivity Network (time frame: Baseline (pre MBSR training) and post-MBSR training (1-6 weeks after MBSR training)). 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 27 Feb 2026.