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

Amy Meadows

Status: Invitation-only

Conditions: Opioid Use Disorder

Treatments: Behavioral: Mobile Mindfulness Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06857968

97193

K23DA054309 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Treatment As Usual First

Active Comparator group

Description:

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

Treatment:

Behavioral: Mobile Mindfulness Training

Mobile Mindfulness First

Experimental group

Description:

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.

Treatment:

Behavioral: Mobile Mindfulness Training