Mindfulness training effects on vaping behavior in teens
Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents
This study tests if mindfulness training can help teens who vape reduce their vaping behavior and improve their ability to manage stress and emotions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06503159 on ClinicalTrials.gov |
What this trial studies
This study investigates the neurobiological effects of a mindfulness-based stress reduction (MBSR) program on adolescents who vape compared to non-vaping peers. Using fMRI, the research aims to assess changes in hippocampal connectivity and how these changes correlate with reductions in vaping behavior. The study also evaluates the feasibility of implementing technology-delivered mindfulness training for adolescents. By comparing frequent nicotine vapers with non-vapers, the study seeks to understand the impact of mindfulness on cognitive control and emotion regulation.
Who should consider this trial
Good fit: Ideal candidates include adolescents aged 13-18 who either vape or do not use nicotine and meet specific eligibility criteria.
Not a fit: Patients with a history of severe substance use disorders or significant mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel intervention to help reduce vaping behaviors in adolescents through mindfulness training.
How similar studies have performed: While mindfulness training has shown promise in various contexts, this specific application in vaping adolescents is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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. 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. 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.
Where this trial is running
Baltimore, Maryland
- National Institute on Drug Abuse — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Betty Jo Salmeron, M.D. — National Institute on Drug Abuse (NIDA)
- Study coordinator: Betty Jo Salmeron, M.D.
- Email: bsalmeron@nih.gov
- Phone: (667) 312-5266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.