Clinical trial NCT06626529: Mindful Breaths: Mindfulness for Young Adult Vaping
Official title: Mindful Breaths: a Pilot Randomized Trial on Mindfulness for Young Adult Vaping
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaping Cessation
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Michigan State University
First posted: 2024-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary efficacy of mindfulness-based interventions (MBI) as a vaping cessation intervention in young adults aged 18-29 who vape nicotine at least 25 days per month and are interested in cutting down or quitting. The main questions it aims to answer are:

* Can mindfulness practice reduce nicotine cravings in young adults?
* Is mindfulness practice an acceptable and feasible intervention for vaping cessation in this population?

Researchers will compare participants in the mindfulness intervention group to a control group that watches a video with calming music and images to see if mindfulness practice has a greater effect on reducing nicotine cravings.

Participants will:

* Complete a baseline survey and craving cue reactivity assessment.
* Engage in a 10-minute guided mindfulness meditation (intervention group) or view calming music and images (control group).
* Rate their cravings and the acceptability, appropriateness, and feasibility of the intervention after the session.


Eligibility criteria: Inclusion Criteria:

* Young adults aged 18-29 years old
* Residing in the United States
* Able to read and speak English
* Vape nicotine at least 25 days/month,
* Interested in cutting down or quitting vaping in the next 30 days (rated at least a 5 on a 10-point scale).

Exclusion Criteria:

* Using any nicotine-containing products other than e-cigarettes
* A current or past Diagnostic and Statistical Manual of Mental Disorders (DSM-5) psychiatric diagnosis of severe mental illness
* A current DSM diagnosis of substance use disorders other than tobacco use disorder
* Involved in regular mindful practice
* Undergoing current smoking/vaping cessation treatment (counseling and/or medication)
* Taking any medications that may potentially affect nicotine craving, consumption, or mood within the past 30 days.

Primary outcomes:
measure: Satisfaction
timeFrame: Within ten minutes after the completion of a single 10-minute guided meditation session
measure: Intervention appeal
timeFrame: Within ten minutes after the completion of a single 10-minute guided meditation session
measure: Intervention appropriateness
timeFrame: Within ten minutes after the completion of a single 10-minute guided meditation session
measure: Intervention feasibility
timeFrame: Within ten minutes after the completion of a single 10-minute guided meditation session
measure: Perceived effectiveness
timeFrame: Within ten minutes after the completion of a single 10-minute guided meditation session
measure: Likelihood to continue mindfulness practice
timeFrame: Within ten minutes after the completion of a single 10-minute guided meditation session
Secondary outcomes:
measure: Craving
timeFrame: Within 20 minutes before and after a ten minute guided mindfulness meditation practice.
Other outcomes:
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