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Clinical Trials/NCT06503159
NCT06503159
Terminated
N/A

Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents

National Institute on Drug Abuse (NIDA)1 site in 1 country14 target enrollmentMay 7, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vaping Teens
Sponsor
National Institute on Drug Abuse (NIDA)
Enrollment
14
Locations
1
Primary Endpoint
To characterize static and dynamic rsFC differences in hippocampal networks related to nicotine vaping in adolescents.
Status
Terminated
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 7, 2025
End Date
September 11, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To characterize static and dynamic rsFC differences in hippocampal networks related to nicotine vaping in adolescents.

Time Frame: 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.

Time Frame: 5.5-7 months

Hippocampal connectivity and d-rsFC measures are related to both nicotine exposure and MBSR training

Secondary Outcomes

  • 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)
  • To assess engagement with a smoking cessation app and changes in various behaviors following MBSR training.(5.5-7 months)

Study Sites (1)

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