Clinical trial NCT06857968: Mobile Mindfulness Training (mMT) for People in Medication Treatment of Opioid Use Disorder (MOUD)
Official title: Improving Opioid Use Disorder Treatment Engagement Using Mobile Mindfulness in Childhood Trauma Survivors
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Opioid Use Disorder
Keywords: opioid use disorder
mindfulness
childhood trauma
treatment
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Feasibility of Access
timeFrame: 75 days after enrollment
measure: Proportion of Acceptability
timeFrame: 75 days after enrollment
Secondary outcomes:
measure: Change in Trauma Symptoms
timeFrame: 180 days after enrollment
measure: Change in Mindfulness
timeFrame: 180 days after enrollment
Other outcomes:
measure: Change in Heart Rate Variability
timeFrame: 180 days after enrollment
measure: Change in inflammatory marker high-sensitivity C-reactive protein
timeFrame: 180 days after enrollment
measure: Change in inflammatory marker interleukin-6
timeFrame: 180 days after enrollment
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Amy Meadows, M.D.
role: PRINCIPAL_INVESTIGATOR
References: