Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-25 @ 6:36 PM
Study NCT ID:
NCT06503159
Status:
TERMINATED
Last Update Posted:
2025-12-23
First Post:
2024-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study
Sponsor:
National Institute on Drug Abuse (NIDA)
Organization:
Study Overview
Official Title:
Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents
Status:
TERMINATED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left NIH.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 001855-DA | None | None | View |