NCT06626529

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

September 29, 2024

Last Update Submit

July 18, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Craving

    Within 20 minutes before and after a ten minute guided mindfulness meditation practice.

Study Arms (2)

Mindfulness

EXPERIMENTAL

Intervention group participants will practice mindfulness following a ten-minute video of guided mindfulness meditation for craving and addiction.

Behavioral: Guided mindfulness meditation

Scenery video

SHAM COMPARATOR

Control group participants will watch a ten-minute video of calming music and images.

Behavioral: Scenery video

Interventions

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.

Mindfulness
Scenery videoBEHAVIORAL

Watching a ten-minute video of calming music and images

Scenery video

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Audrey H Hai

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 4, 2024

Study Start

August 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share