Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study

National Institute on Drug Abuse (NIDA)14 enrolled

Overview

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: 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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

* 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.

Outcomes

Primary Outcomes

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

Time frame: Baseline (pre MBSR training) and post-MBSR training (1-6 weeks after MBSR training)

Secondary Outcomes

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

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

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.

Time frame: 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.

Time frame: Up to 4 months following the MBSR training

Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes