Trial Outcomes & Findings for Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study (NCT NCT06503159)
NCT ID: NCT06503159
Last Updated: 2026-02-27
Results Overview
The change in brain connectivity network from baseline (pre mindfulness-based stress reduction (MBSR) training) to post MBSR functional magnetic resonance imaging (fMRI) brain scan. Analysis will be done as change in brain network connectivity based on pre and post MBSR fMRI scan. Change = post-pre values
TERMINATED
NA
14 participants
Baseline (pre MBSR training) and post-MBSR training (1-6 weeks after MBSR training)
2026-02-27
Participant Flow
Participants were not recruited to the interventional phase due to study termination.
Of the 14 participants consented, one participant was screen failure and one participant did not start due to study termination
Participant milestones
| Measure |
Baseline Group: Non-vapers
Adolescents ages 13-18 years old with no history of nicotine vaping complete structural and resting fMRI of the brain and some questionnaires.
|
Baseline Group: Vapers
Adolescents ages 13-18 years old with history of nicotine vaping, who vape 4-7 days per week, complete structural and resting fMRI of the brain and some questionnaires.
|
Intervention: Mindfulness-based Stress Reduction (MBSR) Training
Adolescents ages 13-18 years old with history of nicotine vaping, from the baseline assessment group complete a 9-week intervention once per week in-person or remote mindfulness-based stress reduction (MBSR) training followed by a post-intervention assessment and a second fMRI brain scan.
|
|---|---|---|---|
|
Baseline Period
STARTED
|
11
|
1
|
0
|
|
Baseline Period
COMPLETED
|
11
|
1
|
0
|
|
Baseline Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Interventional Study
STARTED
|
0
|
0
|
0
|
|
Interventional Study
COMPLETED
|
0
|
0
|
0
|
|
Interventional Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hippocampal Network Changes Following Mindfulness Training in Tobacco Vaping Adolescents in an Open-label, Pilot Study
Baseline characteristics by cohort
| Measure |
Baseline Group: Non-vapers
n=11 Participants
Adolescents ages 13-18 years old with no history of nicotine vaping complete structural and resting fMRI of the brain and some questionnaires.
|
Baseline Group: Vapers
n=1 Participants
Adolescents ages 13-18 years old with history of nicotine vaping, who vape 4-7 days per week, complete structural and resting fMRI of the brain and some questionnaires.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=24 Participants
|
1 participants
n=20 Participants
|
12 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre MBSR training) and post-MBSR training (1-6 weeks after MBSR training)Population: Modified Intention-to-Treat Analysis Dataset. Analysis applies to participants in the MBSR Training group. Participants were not recruited to the interventional phase (MBSR training) due to study termination.
The change in brain connectivity network from baseline (pre mindfulness-based stress reduction (MBSR) training) to post MBSR functional magnetic resonance imaging (fMRI) brain scan. Analysis will be done as change in brain network connectivity based on pre and post MBSR fMRI scan. Change = post-pre values
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (0-3 months pre-MBSR training) & post MBSR training (up to six weeks after MBSR training)Population: Modified Intention-to-Treat Analysis Dataset. Analysis applies to participants in the MBSR Training group. Participants were not recruited to the interventional phase (MBSR training) due to study termination.
Participant self-reported change in vaping behaviors will be assessed as reported change in the number of vaping puffs per day at baseline (0-3 months pre-Mindfulness-based stress reduction (MBSR) training) and post MBSR training (up to six weeks after MBSR training). Change = post -pre values
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 9 weeks during the MBSR trainingPopulation: Modified Intention-to-Treat Analysis Dataset. Analysis applies to participants in the MBSR Training group. Participants were not recruited to the interventional phase (MBSR training) due to study termination.
Participant self-reported level of engagement with mindfulness-based stress reduction (MBSR) training will be assessed as percentage of days participant reports practicing MBSR training. Analysis will be done as percentage of days participants practice MBSR training.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 months following the MBSR trainingPopulation: Modified Intention-to-Treat Analysis Dataset. Analysis applies to participants in the MBSR Training group. Participants were not recruited to the interventional phase (MBSR training) due to study termination.
Participant self-reported level of engagement with the Craving-to-Quit app, which will be tracked as how much participants reported using the craving to quit app post mindfulness-based stress reduction (MBSR) training. Analysis will be done as percentage of days participants use the app.
Outcome measures
Outcome data not reported
Adverse Events
Baseline Group: Non-vapers
Baseline Group: Vapers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Betty Salmeron
National Institute on Drug Abuse (NIDA)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place