Opioid Use Disorder
Conditions
Keywords
opioid use disorder, mindfulness, childhood trauma, 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.
Interventions
BEHAVIORALMobile Mindfulness Training
Participants will be instructed to complete a mobile application-based mindfulness training daily for 30 days.
Sponsors
Amy Meadows
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Access | 75 days after enrollment | Proportion of enrolled participants who access the online mobile mindfulness training (mMT) application at least once. |
| Proportion of Acceptability | 75 days after enrollment | Proportion of enrolled active condition participants who report using the online mobile mindfulness training application at least 25 times in 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Trauma Symptoms | 180 days after enrollment | Self-reported changes in trauma symptoms as measured by the Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 between baseline and 180 days after enrollment. Items are summed to provide a total severity score (range 0-80) with higher scores indicating more symptoms of trauma. |
| Change in Mindfulness | 180 days after enrollment | Self-reported changes in mindfulness between as measured by the Five Factor Mindfulness Questionnaire. The Five Factor Mindfulness Questionnaire (FFMQ). It examines 5 key domains of mindfulness: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Scores range from 39 to 195, with higher scores indicating greater tendency to be mindful. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy Meadows, M.D.
University of Kentucky
Outcome results
None listed