Mobile Mindfulness Training (mMT) for People in Medication Treatment of Opioid Use Disorder (MOUD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile Mindfulness Training.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Opioid Use Disorder Treatment Engagement Using Mobile Mindfulness in Childhood Trauma Survivors
Overview
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.
Interventions
- Behavioral Mobile Mindfulness Training
Participants will be instructed to complete a mobile application-based mindfulness training daily for 30 days.
Primary outcome measures
- Feasibility of Access [Time frame: 75 days after enrollment]
- Proportion of Acceptability [Time frame: 75 days after enrollment]
Secondary outcome measures (2)
- Change in Trauma Symptoms [Time frame: 180 days after enrollment]
- Change in Mindfulness [Time frame: 180 days after enrollment]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT06857968 · 97193 · K23DA054309