Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 001855-DA |
Not provided
Not provided
Not provided
Administrative closure (PI unavailability)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Secondary Objectives:
Endpoints:
Primary Endpoints:
Secondary Endpoint:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) Program | Behavioral | The study intervention is a 9-week MBSR intervention once per week in-person or remotely |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (pre MBSR training) and post-MBSR training (1-6 weeks after MBSR training) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (0-3 months pre-MBSR training) & post MBSR training (up to six weeks after MBSR training) |
Not provided
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Non-Vaping group:
Vaping group:
EXCLUSION CRITERIA:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Betty Jo Salmeron, M.D. | National Institute on Drug Abuse (NIDA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute on Drug Abuse | Baltimore | Maryland | 21224 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 14 participants consented, one participant was screen failure and one participant did not start due to study termination
Participants were not recruited to the interventional phase due to study termination.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Baseline Group: Non-vapers | Adolescents ages 13-18 years old with no history of nicotine vaping complete structural and resting fMRI of the brain and some questionnaires. |
| FG001 | Baseline Group: Vapers |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline Period |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| functional magnetic resonance imaging (fMRI) | Other | One fMRI scan for the baseline group and two scans for the interventional group |
|
| 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. | 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. | Up to 4 months following the MBSR training |
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.
| FG002 | Intervention: Mindfulness-based Stress Reduction (MBSR) Training | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Interventional Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Group: Non-vapers | Adolescents ages 13-18 years old with no history of nicotine vaping complete structural and resting fMRI of the brain and some questionnaires. |
| BG001 | Baseline Group: Vapers | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Modified Intention-to-Treat Analysis Dataset. Analysis applies to participants in the MBSR Training group. Participants were not recruited to the interventional phase (MBSR training) due to study termination. | Posted | Baseline (pre MBSR training) and post-MBSR training (1-6 weeks after MBSR training) |
|
| |||||||||||||||||||
| Secondary | 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 | Modified Intention-to-Treat Analysis Dataset. Analysis applies to participants in the MBSR Training group. Participants were not recruited to the interventional phase (MBSR training) due to study termination. | Posted | Baseline (0-3 months pre-MBSR training) & post MBSR training (up to six weeks after MBSR training) |
|
| |||||||||||||||||||
| Secondary | 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. | Modified Intention-to-Treat Analysis Dataset. Analysis applies to participants in the MBSR Training group. Participants were not recruited to the interventional phase (MBSR training) due to study termination. | Posted | Up to 9 weeks during the MBSR training |
|
| |||||||||||||||||||
| Secondary | 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. | Modified Intention-to-Treat Analysis Dataset. Analysis applies to participants in the MBSR Training group. Participants were not recruited to the interventional phase (MBSR training) due to study termination. | Posted | Up to 4 months following the MBSR training |
|
|
One day - study visit date only
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline Group: Non-vapers | Adolescents ages 13-18 years old with no history of nicotine vaping complete structural and resting fMRI of the brain and some questionnaires. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG001 | Baseline Group: Vapers | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
Not provided
Study was terminated before start of subject recruitment to the interventional phase.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Betty Salmeron | National Institute on Drug Abuse (NIDA) | 667-312-5266 | bsalmeron@intra.nida.nih.gov |
| Dec 31, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|