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OpenTrials
Enrolling by Invitation

NCT Number: NCT06857968

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

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.

Enrolling by Invitation

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40509, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mobile Mindfulness Training

Behavioral

Participants will be instructed to complete a mobile application-based mindfulness training daily for 30 days.

Other names: Headspace

Primary outcomes

  1. Feasibility of Access

    Time frame: 75 days after enrollment

    Proportion of enrolled participants who access the online mobile mindfulness training (mMT) application at least once.

  2. Proportion of Acceptability

    Time frame: 75 days after enrollment

    Proportion of enrolled active condition participants who report using the online mobile mindfulness training application at least 25 times in 30 days.

Secondary outcomes

  1. Change in Trauma Symptoms

    Time frame: 180 days after enrollment

    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.

  2. Change in Mindfulness

    Time frame: 180 days after enrollment

    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.

Other outcomes

  1. Change in Heart Rate Variability

    Time frame: 180 days after enrollment

    Change in high frequency heart rate variability between baseline and 180 days after enrollment.

  2. Change in inflammatory marker high-sensitivity C-reactive protein

    Time frame: 180 days after enrollment

    Change in high sensitivity C-reactive protein (hsCRP) between baseline and 180 days after enrollment.

  3. Change in inflammatory marker interleukin-6

    Time frame: 180 days after enrollment

    Change in interleukin-6 (IL6) between baseline and 180 days post-enrollment.

Sponsors and collaborators

Lead sponsor

Amy Meadows

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 5, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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