Mobile Mindfulness Training (mMT) for People in Medication Treatment of Opioid Use Disorder (MOUD)

Improving Opioid Use Disorder Treatment Engagement Using Mobile Mindfulness in Childhood Trauma Survivors

The goal of this clinical trial is to learn if mobile mindfulness training can help people in treatment for opioid use disorder. The main questions it aims to answer are:

• Will people with opioid use disorder and childhood trauma use mobile mindfulness training?
• Will mobile mindfulness training help people with opioid use disorder and childhood trauma have decreased markers of psychological stress?

Participants will:

Be given access to mobile mindfulness training and encouragement to use it daily for 30 days.

Keep a diary of how often mobile mindfulness training is used. Visit the clinic four times to measure stress levels, including written rating scales, blood work, and heart rate tests.

Study Overview

• Status: Enrolling by invitation
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: Mobile Mindfulness Training

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • University of Kentucky

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Clinically diagnosed with Opioid Use Disorder (per DSM5 criteria)
• Currently enrolled in treatment for Opioid Use Disorder at a clinic affiliated with UKHealthCare or University of Kentucky
• On a stable dose of buprenorphine, buprenorphine/naloxone, or naloxone (i.e., at least 30 days post-induction and on a stable dose for 30 days)
• Able to read and understand English
• Have a history of childhood trauma as measured by the Adverse Childhood Experiences scale and/or Childhood Trauma Questionnaire.

Exclusion Criteria:

• Currently taking a beta-blocker, calcium-channel blocker, antiarrhythmic, corticosteroid, or immune modulator medication
• Uncontrolled acute or chronic health conditions (e.g., active infections, autoimmune conditions, cancer undergoing active treatment)
• Current or expected pregnancy
• Current mindfulness practice (i.e., participant reports practicing mindfulness for 10 minutes or more per week)
• Primary psychotic illness
• Diagnosis of a disorder known to interfere with neurocognitive function (e.g., estimated full scale IQ below 70 or diagnosis of dementia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment As Usual First; This is a crossover trial. Participants in this study arm will have 30 days of treatment as usual then a 14 day washout and then 30 days of mobile mindfulness training	Behavioral: Mobile Mindfulness Training; Participants will be instructed to complete a mobile application-based mindfulness training daily for 30 days.; Other Names: Headspace
Experimental: Mobile Mindfulness First; This is a crossover trial. Participants in this arm will have 30 days of mobile mindfulness training first then a 14 day washout and then 30 days of treatment as ususal.	Behavioral: Mobile Mindfulness Training; Participants will be instructed to complete a mobile application-based mindfulness training daily for 30 days.; Other Names: Headspace

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Access	Proportion of enrolled participants who access the online mobile mindfulness training (mMT) application at least once.	75 days after enrollment
Proportion of Acceptability	Proportion of enrolled active condition participants who report using the online mobile mindfulness training application at least 25 times in 30 days.	75 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Trauma Symptoms	Self-reported changes in trauma symptoms as measured by the Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 between baseline and 180 days after enrollment. Items are summed to provide a total severity score (range 0-80) with higher scores indicating more symptoms of trauma.	180 days after enrollment
Change in Mindfulness	Self-reported changes in mindfulness between as measured by the Five Factor Mindfulness Questionnaire. The Five Factor Mindfulness Questionnaire (FFMQ). It examines 5 key domains of mindfulness: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Scores range from 39 to 195, with higher scores indicating greater tendency to be mindful.	180 days after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Heart Rate Variability	Change in high frequency heart rate variability between baseline and 180 days after enrollment.	180 days after enrollment
Change in inflammatory marker high-sensitivity C-reactive protein	Change in high sensitivity C-reactive protein (hsCRP) between baseline and 180 days after enrollment.	180 days after enrollment
Change in inflammatory marker interleukin-6	Change in interleukin-6 (IL6) between baseline and 180 days post-enrollment.	180 days after enrollment

Collaborators and Investigators

• Sponsor: Amy Meadows
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Amy Meadows, M.D., University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: treatment; mindfulness; opioid use disorder; childhood trauma
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 97193; K23DA054309 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study period, all identifiers will be removed from data and specimen, but the de-identified dataset free of PHI specifiers will be uploaded to a data sharing service.
• IPD Sharing Time Frame: Beginning 1 year after publication with no end date
• IPD Sharing Access Criteria: Data will be available in a data sharing repository

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