Mindfulness Training for Vaping Teens

Overseen By Betty Jo Salmeron, M.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: National Institute on Drug Abuse (NIDA)

Must not be taking: Psychotropic medications

Disqualifiers: Chronic medical, Neurological, Neurodevelopmental, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mindfulness-based stress reduction (MBSR) program affects the brain and reduces vaping among teens. Researchers aim to determine if mindfulness training alters brain activity associated with vaping and whether these changes reduce vaping habits. The study includes teens who either vape regularly or have little to no vaping history. Suitable candidates are adolescents aged 13-18 who have vaped nicotine products at least 10 times in the past month or have used nicotine no more than five times in their life. Participants must have a smartphone and not engage in regular meditation or yoga practices. As an unphased trial, this study offers teens a unique opportunity to contribute to groundbreaking research on mindfulness and vaping.

Will I have to stop taking my current medications?

The trial requires that if you are on medication for depression, anxiety, or ADHD, your dose must have been stable for the past 3 months. So, you won't need to stop taking your current medications, but you shouldn't change the dose either.

What prior data suggests that this mindfulness-based stress reduction program is safe for adolescents?

Research has shown that mindfulness-based stress reduction (MBSR) is generally safe. Medical settings have used this program for over 20 years to address various health issues without causing serious side effects. Some individuals might experience mild discomfort, such as a temporary increase in anxiety or emotional sensitivity, but these feelings typically do not last long and are manageable. Overall, MBSR is well-tolerated, making it a safe choice for most people, including teenagers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for vaping addiction focus on nicotine replacement or behavioral therapy. But the Mindfulness-based Stress Reduction (MBSR) Program offers a fresh approach by using mindfulness to help teens manage their stress and cravings. This method is unique because it employs both in-person and technology-delivered training, which could make it more accessible and engaging for adolescents. Researchers are excited about this trial as it uses fMRI to explore how mindfulness might change brain patterns linked to vaping, potentially offering deeper insights into how to effectively curb this habit among teens.

What evidence suggests that this mindfulness-based stress reduction program is effective for reducing vaping in teens?

Research has shown that mindfulness-based stress reduction (MBSR), which participants in this trial will receive, can lower stress, anxiety, and depression. This is promising for teens who vape, as these feelings often lead to nicotine use. One study found that mindfulness training reduced stress more effectively than other programs. Although direct evidence about vaping is limited, a similar method using text messages helped teens quit vaping. These findings suggest that MBSR might help reduce vaping by addressing the stress and emotions that often cause it. ^{5 6 7 8 9}

Who Is on the Research Team?

Betty Jo Salmeron, M.D.

Principal Investigator

National Institute on Drug Abuse (NIDA)

Are You a Good Fit for This Trial?

This trial is for healthy teenagers who vape and are interested in trying a mindfulness-based stress reduction program to potentially reduce their vaping habits. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am a teenager, aged 13-18, and currently in high school.

My parents or guardian have agreed to my participation if I'm 17 or under and not vaping.

Non-Vaping group: No MRI contraindications

Exclusion Criteria

I had a serious brain injury with either a loss of consciousness for over 30 minutes or lasting effects.

Chronic medical conditions associated with cerebral blood flow abnormalities per PI/MAI determination after review of medical history

Current regular meditation or yoga practice averaging >10 min/day for >2 days per week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness-based Stress Reduction (MBSR) Training

Participants undergo in-person and technology-delivered mindfulness-based stress reduction training to study neurobehavioral correlates of nicotine vaping

5.5-7 months

Follow-up

Participants are monitored for changes in vaping behavior, emotion regulation, and engagement with a smoking cessation app after MBSR training

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness-based Stress Reduction (MBSR) Program

Trial Overview The study tests how an online mindfulness training program affects brain connections related to memory and emotion (hippocampal networks) and if these changes can predict a decrease in tobacco vaping among teens.

How Is the Trial Designed?

Group I: Mindfulness-based Stress Reduction (MBSR) Program Experimental Treatment 1 Intervention

This protocol will use fMRI and in-person and technology-delivered mindfulness-based stress reduction (MBSR) training to elucidate neurobehavioral correlates of regular nicotine vaping in adolescents compared to non-vaping adolescents, and changes in these correlates after MBSR training.

Who Is Running the Clinical Trial?

National Institute on Drug Abuse (NIDA)

Lead Sponsor

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

The Journeys to Wellness trial successfully adapted the standard 8-week mindfulness-based stress reduction (MBSR) program into a workshop and teleconference format (tMBSR) for 63 kidney transplant candidates, showing high attendance and satisfaction rates among participants.

Participants in the tMBSR group reported significantly higher expectations of the intervention's usefulness for managing their health (83%) compared to the tSupport group (43%), indicating a positive reception and potential efficacy of the mindfulness training for improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. Reilly-Spong, M., Reibel, D., Pearson, T., et al.[2022]

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

A systematic review of 18 studies found that Mindfulness Based Stress Reduction (MBSR) therapy significantly improves the conditions of patients with chronic illnesses such as cancer, hypertension, and diabetes.

MBSR offers a promising alternative treatment method that helps patients manage their diseases more effectively, although more research is needed to fully understand its mechanisms and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. Niazi, AK., Niazi, SK.[2022]

An eight-week study involving 63 participants compared the effects of Mindfulness Based Stress Reduction (MBSR) to an active control group (Health Enhancement Program) on sustained attention, but found no significant differences in improvement between the two groups.

While MBSR did not enhance sustained attention, there was some evidence of improved visual discrimination, suggesting that mindfulness training may have specific benefits, but further research is needed to clarify its effects on different aspects of attention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control. MacCoon, DG., MacLean, KA., Davidson, RJ., et al.[2022]

Mindfulness-Based Stress Reduction (MBSR) is a program designed to help individuals manage stress and emotions through mindfulness meditation, but current research shows significant methodological issues and a lack of robust evidence regarding its effectiveness.

While there is some preliminary evidence suggesting MBSR may be beneficial, the overall findings do not strongly support its widespread endorsement, indicating a need for more rigorous research to better understand its efficacy and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we really know about mindfulness-based stress reduction? Bishop, SR.[2022]

The mindfulness-based stress reduction (MBSR) program significantly helped mental health professionals reduce their work stress and improve their self-care, which in turn enhanced patient care.

Participants in the MBSR program reported increased patient satisfaction and a reduction in patient safety events, indicating a positive impact on both staff well-being and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of mindfulness meditation in promoting a culture of safety on an acute psychiatric unit. Brady, S., O'Connor, N., Burgermeister, D., et al.[2012]

In a study of 66 healthy adults, 8 weeks of aerobic exercise training (AET) significantly increased the time spent in moderate-to-vigorous physical activity (MVPA) compared to a no-treatment control, suggesting AET is effective for enhancing physical activity levels.

Mindfulness-based stress reduction (MBSR) training appeared to help mitigate the decrease in physical activity typically associated with shorter days and cooler weather, indicating its potential role in maintaining exercise participation during challenging seasonal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity. Meyer, JD., Torres, ER., Grabow, ML., et al.[2020]

Citations

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Mindfulness for smoking cessation - PMC - PubMed Central One study found a greater reduction in perceived stress in participants who received a face‐to‐face mindfulness training programme versus an intensity‐matched ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2822082

A Vaping Cessation Text Message Program for Adolescent ... Point-prevalence abstinence rates were 37.8% (95% CI, 34.4%-41.3%) among intervention participants and 28.0% (95% CI, 24.9%-31.3%) among control ...

3. withpower.com withpower.com/trial/phase-healthy-subjects-hs-8-2024-90bc1

Mindfulness Training for Vaping Teens Mindfulness-based Stress Reduction (MBSR) has been shown to help reduce symptoms of stress, anxiety, and depression in various groups, which suggests it might ...

4. scholarsrepository.llu.edu scholarsrepository.llu.edu/cgi/viewcontent.cgi?article=3502&context=etd

Mediators of the Relationship between Mindfulness and E These results suggest that mindfulness and mindfulness-based interventions may play an important role in health-related outcomes. Mindfulness and E-cigarettes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11307165/

A Vaping Cessation Text Message Program for Adolescent ... A tailored, interactive text message program increased self-reported vaping cessation rates among adolescents recruited via social media channels.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9379793/

Mindfulness-Based Smoking Cessation Delivered Through ... Mindfulness training can increase the rates of smoking cessation and lapse recovery, and telehealth and SMS text messaging have the potential to provide more ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030646031730031X

Efficacy of mindfulness meditation for smoking cessation Overall, mindfulness meditation did not have significant effects on abstinence or cigarettes per day, relative to comparator groups.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05557643

PAPR: PAP + MBSR for Front-line Healthcare Provider ... This project is an open-label randomized study looking at an 8-week Mindfulness-Based Stress Reduction (MBSR) curriculum vs. an 8-week MBSR curriculum + a ...

9. digitalcommons.fiu.edu digitalcommons.fiu.edu/cgi/viewcontent.cgi?article=1342&context=cnhs-studentprojects

The Effectiveness of Mindfulness-Based Stress Reduction ... PURPOSE: The purpose of this DNP project was to evaluate the effectiveness of a Mindfulness-Based. Stress Reduction (MBSR) program in reducing ...