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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-29

Study Completion Date

2029-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Mobile Mindfulness Training

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Mobile Mindfulness Training

Intervention Type BEHAVIORAL

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

Interventions

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Mobile Mindfulness Training

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Headspace

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No