Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study

NCT ID: NCT06503159

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-07
• Study Completion Date: 2025-09-11

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.

Conditions

Vaping Teens; Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness-based Stress Reduction (MBSR) Program

Intervention Type: BEHAVIORAL

The study intervention is a 9-week MBSR intervention once per week in-person or remotely (via an NIH approved remote platform used in compliance with policy, including HRPP Policy 303). The MBSR will be delivered to groups of 8-12 participants. Only the vaping adolescents will receive MBSR training.

Interventions

Mindfulness-based Stress Reduction (MBSR) Program

The study intervention is a 9-week MBSR intervention once per week in-person or remotely (via an NIH approved remote platform used in compliance with policy, including HRPP Policy 303). The MBSR will be delivered to groups of 8-12 participants. Only the vaping adolescents will receive MBSR training.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betty Jo Salmeron, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute on Drug Abuse (NIDA)

Locations

National Institute on Drug Abuse

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

10001855

Identifier Type: -

Identifier Source: org_study_id

001855-DA

Identifier Type: -

Identifier Source: secondary_id