Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT06503159
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT06503159
Study Brief:
Protocol Section:
NCT06503159