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

NCT06503159 | Terminated Results

• 2 other identifiers: 10001855001855-DA
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaping Teens; Healthy Volunteers

Keywords

Natural History; Teen; Nicotine; Vape

Outcome Measures

Primary Outcomes (1)

• Change in Brain Connectivity Network

  The change in brain connectivity network from baseline (pre mindfulness-based stress reduction (MBSR) training) to post MBSR functional magnetic resonance imaging (fMRI) brain scan. Analysis will be done as change in brain network connectivity based on pre and post MBSR fMRI scan. Change = post-pre values

  Baseline (pre MBSR training) and post-MBSR training (1-6 weeks after MBSR training)

Secondary Outcomes (3)

• Participant Self-report Change in Vaping Behaviors

  Baseline (0-3 months pre-MBSR training) & post MBSR training (up to six weeks after MBSR training)

• Participant Self-report Engagement With Mindfulness-based Stress Reduction (MBSR) Training

  Up to 9 weeks during the MBSR training

• Participant Self-report Engagement With the Craving-to-Quit App

  Up to 4 months following the MBSR training

Study Arms (3)

Baseline group: Vapers

EXPERIMENTAL

Adolescents ages 13-18 years old with history of nicotine vaping, who vape 4-7 days per week, complete structural and resting fMRI of the brain and some questionnaires.

Other: functional magnetic resonance imaging (fMRI)

Baseline group: Non-vapers

EXPERIMENTAL

Adolescents ages 13-18 years old with no history of nicotine vaping complete structural and resting fMRI of the brain and some questionnaires.

Other: functional magnetic resonance imaging (fMRI)

Intervention: Mindfulness-based stress reduction (MBSR) training

EXPERIMENTAL

Adolescents ages 13-18 years old with history of nicotine vaping, from the baseline assessment group complete a 9-week intervention once per week in-person or remote mindfulness-based stress reduction (MBSR) training followed by a post-intervention assessment and a second fMRI brain scan.

Behavioral: Mindfulness-based Stress Reduction (MBSR) Program; Other: functional magnetic resonance imaging (fMRI)

Interventions

functional magnetic resonance imaging (fMRI) OTHER

One fMRI scan for the baseline group and two scans for the interventional group

Baseline group: Non-vapers; Baseline group: Vapers; Intervention: Mindfulness-based stress reduction (MBSR) training

Mindfulness-based Stress Reduction (MBSR) Program BEHAVIORAL

The study intervention is a 9-week MBSR intervention once per week in-person or remotely

Intervention: Mindfulness-based stress reduction (MBSR) training

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Non-Vaping group:
• For adolescents aged 17 and under, parental/guardian informed consent to participate in the study
• English language fluency
• Males and females; Age 13-18 enrolled in grades 9-12, or the summer after graduation.
• No MRI contraindications
• No evidence of current psychosis, mania, or significant suicidality
• If on medication for depression, anxiety or ADHD, dose has been stable for 3 months
• No DSM-5 diagnosis of moderate or severe substance use disorder (SUD) related to a psychoactive substance, including tobacco, in the past year
• Access to necessary resources for participating in a technology-based intervention, which includes smartphone ownership for this study
• No use of nicotine more than five (5) times in their life, and none at all in the last 30 days prior to enrollment.
• Vaping group:
• For adolescents aged 17 and under, parental/guardian informed consent to participate in the study
• English language fluency
• Males and females; Age 13-18 enrolled in grades 9-12, or the summer after graduation.

You may not qualify if:

• 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:
• Chronic medical conditions associated with cerebral blood flow abnormalities per PI/MAI determination after review of the medical history.
• Neurological conditions that may interfere with MRI data quality per PI/MAI determination after review of the medical history.
• Neurodevelopmental disorders that are likely to significantly affect data in the judgment of the MAI/PI
• Non-penetrating traumatic brain injury with loss of consciousness \> 30 minutes or significant sequelae persisting longer than two weeks or any penetrating traumatic brain injury.
• Changing dose of psychotropic medication in past three months
• Current regular meditation or yoga practice averaging \>10 min/day for \>2 days per week
• Pregnancy, self-report upon protocol entry, but by urine test prior to MRI scan.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Study was terminated before start of subject recruitment to the interventional phase.

Results Point of Contact

• Title: Dr. Betty Salmeron
• Organization: National Institute on Drug Abuse (NIDA)

bsalmeron@intra.nida.nih.gov

667-312-5266

Study Officials

• Betty Jo Salmeron, M.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 16, 2024
• Study Start: May 7, 2025
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)