Mindful Breaths: Mindfulness for Young Adult Vaping

Mindful Breaths: A Pilot Randomized Trial on Mindfulness for Young Adult Vaping

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaping Cessation
• Intervention / Treatment: Behavioral: Guided mindfulness meditation; Behavioral: Scenery video

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Audrey H Hai; Phone Number: 504-247-1457; Email: ahai@tulane.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; Intervention group participants will practice mindfulness following a ten-minute video of guided mindfulness meditation for craving and addiction.	Behavioral: Guided mindfulness meditation; Watching a video of a guided mindfulness meditation include paying attention to the breath, promoting natural breathing without force; body scan, directing awareness from the head down to the toes, allowing tension to release in each area. The intervention emphasizes observing sensations without judgment, fostering a state of relaxed awareness.
Sham Comparator: Scenery video; Control group participants will watch a ten-minute video of calming music and images.	Behavioral: Scenery video; Watching a ten-minute video of calming music and images

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction	Satisfaction with the mindfulness intervention will be rated on a scale of 1-5, with a higher score indicating higher satisfaction.	Within ten minutes after the completion of a single 10-minute guided meditation session
Intervention appeal	Intervention appeal will be rated on a scale of 1-5, with a higher score indicating greater appeal.	Within ten minutes after the completion of a single 10-minute guided meditation session
Intervention appropriateness	Intervention appropriateness will be rated on a scale of 1-5, with a higher score indicating greater appropriateness.	Within ten minutes after the completion of a single 10-minute guided meditation session
Intervention feasibility	Intervention feasibility will be rated on a scale of 1-5, with a higher score indicating higher feasibility.	Within ten minutes after the completion of a single 10-minute guided meditation session
Perceived effectiveness	Perceived intervention effectiveness will be rated on a scale of 1-5, with a higher score indicating greater effectiveness.	Within ten minutes after the completion of a single 10-minute guided meditation session
Likelihood to continue mindfulness practice	The likelihood of continuing the mindfulness practice will be rated on a scale of 1-5, with a higher score indicating a higher likelihood of continuing the mindfulness practice.	Within ten minutes after the completion of a single 10-minute guided meditation session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving	Craving for e-cigarettes will be measured with the adapted Visual Analog Craving Scale before and after each cue and the intervention/control to assess their craving intensity. Participants rate craving intensity by selecting a position along a line anchored on the left by "not at all" and on the right by "more than ever."	Within 20 minutes before and after a ten minute guided mindfulness meditation practice.

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: Michigan State University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-1480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No