Status:
TERMINATED
Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Vaping Teens
Healthy Volunteers
Eligibility:
All Genders
13-18 years
Phase:
NA
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 al...
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 va...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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 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 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.
- 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 SUD related to another psychoactive substance (other than tobacco) in the past year
- Vape a nicotine containing product at least 10 days in the past 30 days
- 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:
- 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 sequalae persisting longer than 2 weeks or any penetrating traumatic brain injury.
- Changing dose of psychotropic medication in past 3 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.
Exclusion
Key Trial Info
Start Date :
May 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06503159
Start Date
May 7 2025
End Date
September 11 2025
Last Update
December 23 2025
Active Locations (1)
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1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224