TERMINATED

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

Conditions

Vaping Teens Healthy Volunteers Natural History Teen Nicotine Vape

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents

Quick Facts

Study Start:2025-05-07

Study Completion:2025-09-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06503159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
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. 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	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.

Inclusion Criteria

Exclusion Criteria

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.
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

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.

Contacts and Locations

Principal Investigator

Betty Jo Salmeron, M.D.

PRINCIPAL_INVESTIGATOR

National Institute on Drug Abuse (NIDA)

Study Locations (Sites)

National Institute on Drug Abuse

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: National Institute on Drug Abuse (NIDA)

Betty Jo Salmeron, M.D., PRINCIPAL_INVESTIGATOR, National Institute on Drug Abuse (NIDA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-07

Study Completion Date2025-09-11

Study Record Updates

Study Start Date2025-05-07

Study Completion Date2025-09-11

Terms related to this study

Keywords Provided by Researchers

Natural History
Teen
Nicotine
Vape

Additional Relevant MeSH Terms

Vaping Teens
Healthy Volunteers