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

NCT06857968 | Enrolling By Invitation DMC

• 2 other identifiers: 97193K23DA054309
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

opioid use disorder; mindfulness; childhood trauma; treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Trauma Symptoms

  180 days after enrollment

• Change in Mindfulness

  180 days after enrollment

Other Outcomes (3)

• Change in Heart Rate Variability

  180 days after enrollment

• Change in inflammatory marker high-sensitivity C-reactive protein

  180 days after enrollment

• Change in inflammatory marker interleukin-6

  180 days after enrollment

Study Arms (2)

Treatment As Usual First

ACTIVE COMPARATOR

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

Mobile Mindfulness First

EXPERIMENTAL

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

Interventions

Mobile Mindfulness Training BEHAVIORAL

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

Also known as: Headspace

Mobile Mindfulness First; Treatment As Usual First

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amy Meadows: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40509, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Amy Meadows, M.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 5, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 5, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: Data will be available in a data sharing repository

Locations

US (1)