Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503159
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-13
Brief Title:
Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents
Status:
RECRUITING
Status Verified Date:
2024-07-31
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 DeltarsFC 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 eg 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 nonvaping 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 and task-based activation
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 PrePost MBSR training
Secondary Endpoints
Engagement with MBSR training and post-training Craving-to-Quit app and change scores for other behavioral measure eg vaping emotion regulation
rsFC from seeds such as dorsal anterior cingulate and taskbased activation
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 eg 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 nonvaping 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 and task-based activation
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 PrePost MBSR training
Secondary Endpoints
Engagement with MBSR training and post-training Craving-to-Quit app and change scores for other behavioral measure eg vaping emotion regulation
rsFC from seeds such as dorsal anterior cingulate and taskbased activation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None