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Protocol Details

Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001855-DA

Sponsoring Institute

National Institute on Drug Abuse (NIDA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 13 Years
Max Age: 18 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women;
Non-English Speaking;
Neonates;
Fetuses;
Adults who are or may become unable to consent

Keywords

Natural History;
Teen;
Nicotine;
Vape

Recruitment Keyword(s)

None

Condition(s)

Vaping Teens;
Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Behavioral: Mindfulness-based Stress Reduction (MBSR) Program

Supporting Site

National Institute on Drug Abuse

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Betty Jo Salmeron, M.D.
National Institute on Drug Abuse (NIDA)
NIH BIOMEDICAL RESEARCH CENTER BG RM 07A717
251 BAYVIEW BLVD.
BALTIMORE MD 21224
(667) 312-5266
bsalmeron@intra.nida.nih.gov

Betty Jo Salmeron, M.D.
National Institute on Drug Abuse (NIDA)
NIH BIOMEDICAL RESEARCH CENTER BG RM 07A717
251 BAYVIEW BLVD.
BALTIMORE MD 21224
(667) 312-5266
bsalmeron@nih.gov

Betty Jo Salmeron, M.D.
NIH BIOMEDICAL RESEARCH CENTER BG RM 07A717
251 BAYVIEW BLVD.
BALTIMORE MD 21224
(667) 312-5266
bsalmeron@intra.nida.nih.gov

Clinical Trials Number:

NCT06503159

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