Clinical trial NCT06503159: Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study
Official title: Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaping Teens
Healthy Volunteers
Keywords: Natural History
Teen
Nicotine
Vape
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2024-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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 dynamicrsFC 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 dynamicrsFC measures within the nicotine vaping group Pre/Post MBSR training.

Secondary Endpoint:

* Engagement with MBSR training and post-training Cravingto- Quit app and change scores for other behavioral measure (e.g. vaping, emotion regulation).
* rsFC from seeds such as dorsal anterior cingulate.

Eligibility 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 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 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 ADHD, dose has been stable for 3 months
7. No 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 sequalae persisting longer than 2 weeks or any penetrating traumatic brain injury.
5. Changing dose of psychotropic medication in past 3 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.

Primary outcomes:
measure: To characterize rsFC changes ((Delta)rsFC) in hippocampal networks and d-rsFC following a technology-delivered MBSR program in nicotine vaping adolescents.
timeFrame: 5.5-7 months
measure: To characterize static and dynamic rsFC differences in hippocampal networks related to nicotine vaping in adolescents.
timeFrame: 5.5-7 months
Secondary outcomes:
measure: To assess other imaging metrics such as resting connectivity from alternative sites related to mindfulness meditation and nicotine dependence (e.g., dACC) between vaping and non-vaping teens and pre-/post-MBSR tr
timeFrame: 5.5-7 months
measure: To assess engagement with a smoking cessation app and changes in various behaviors following MBSR training.
timeFrame: 5.5-7 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute on Drug Abuse
state: Maryland
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Betty Jo Salmeron, M.D.
role: PRINCIPAL_INVESTIGATOR
References: