Healthy Volunteers, Vaping Teens
Conditions
Keywords
Natural History, Teen, Nicotine, Vape
Brief 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 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: 1. To characterize static and dynamic rsFC of hippocampal networks in frequent nicotine vaping adolescents compared to non-vaping adolescents. 2. 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.
Interventions
The study intervention is a 9-week MBSR intervention once per week in-person or remotely
OTHERfunctional magnetic resonance imaging (fMRI)
One fMRI scan for the baseline group and two scans for the interventional group
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Non-Vaping group: 1. For adolescents aged 17 and under, parental/guardian informed consent to participate in the study 2. English language fluency 3. Males and females; Age 13-18 enrolled in grades 9-12, or the summer after graduation. 4. No MRI contraindications 5. No evidence of current psychosis, mania, or significant suicidality 6. If on medication for depression, anxiety or ADHD, dose has been stable for 3 months 7. No DSM-5 diagnosis of moderate or severe substance use disorder (SUD) related to a psychoactive substance, including tobacco, in the past year 8. Access to necessary resources for participating in a technology-based intervention, which includes smartphone ownership for this study 9. 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: 1. For adolescents aged 17 and under, parental/guardian informed consent to participate in the study 2. English language fluency 3. Males and females; Age 13-18 enrolled in grades 9-12, or the summer after graduation. 4. No MRI contraindications 5. No evidence of current psychosis, mania, or significant suicidality 6. If on medication for depression, anxiety or attention deficit hyperactivity disorder (ADHD), dose has been stable for 3 months 7. 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 8. Vape a nicotine containing product at least 10 days in the past 30 days 9. Access to necessary resources for participating in a technology-based intervention, which includes smartphone ownership for this study
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: 1. Chronic medical conditions associated with cerebral blood flow abnormalities per PI/MAI determination after review of the medical history. 2. Neurological conditions that may interfere with MRI data quality per PI/MAI determination after review of the medical history. 3. Neurodevelopmental disorders that are likely to significantly affect data in the judgment of the MAI/PI 4. 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. 5. Changing dose of psychotropic medication in past three months 6. Current regular meditation or yoga practice averaging \>10 min/day for \>2 days per week 7. Pregnancy, self-report upon protocol entry, but by urine test prior to MRI scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brain Connectivity Network | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Self-report Change in Vaping Behaviors | Baseline (0-3 months pre-MBSR training) & post MBSR training (up to six weeks after MBSR training) | 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 |
| Participant Self-report Engagement With Mindfulness-based Stress Reduction (MBSR) Training | Up to 9 weeks during the 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. |
| Participant Self-report Engagement With the Craving-to-Quit App | Up to 4 months following the MBSR training | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBetty Jo Salmeron, M.D.
National Institute on Drug Abuse (NIDA)
Participant flow
Recruitment details
Participants were not recruited to the interventional phase due to study termination.
Pre-assignment details
Of the 14 participants consented, one participant was screen failure and one participant did not start due to study termination
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 12 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 1 |
| other Total, other adverse events | 0 / 11 | 0 / 1 |
| serious Total, serious adverse events | 0 / 11 | 0 / 1 |
Outcome results
None listed