Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study
- Conditions
- Healthy VolunteersVaping Teens
- Interventions
- Behavioral: Mindfulness-based Stress Reduction (MBSR) Program
- Registration Number
- NCT06503159
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mindfulness-based Stress Reduction (MBSR) Program Mindfulness-based Stress Reduction (MBSR) Program 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.
- Primary Outcome Measures
Name Time Method To characterize static and dynamic rsFC differences in hippocampal networks related to nicotine vaping in adolescents. 5.5-7 months Hippocampal networks are related to nicotine exposure, especially in adolescence.
To characterize rsFC changes ((Delta)rsFC) in hippocampal networks and d-rsFC following a technology-delivered MBSR program in nicotine vaping adolescents. 5.5-7 months Hippocampal connectivity and d-rsFC measures are related to both nicotine exposure and MBSR training
- Secondary Outcome Measures
Name Time Method 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 5.5-7 months These metrics will provide a fuller understanding of teen vaping and the effects of MBSR training.
To assess engagement with a smoking cessation app and changes in various behaviors following MBSR training. 5.5-7 months Understanding feasibility and acceptability as well as efficacy is important in assessing potential for development of MBSR training as a new therapeutic intervention for vaping-related TUD in youth.
Trial Locations
- Locations (1)
National Institute on Drug Abuse
🇺🇸Baltimore, Maryland, United States