[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06857968":3,"trial-entities:NCT06857968":97,"trial-summary:NCT06857968":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":42,"secondary_outcomes":50,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":77,"locations":80,"central_contacts":90,"overall_officials":91,"references":95,"see_also_links":96},"NCT06857968","97193","Mobile Mindfulness Training (mMT) for People in Medication Treatment of Opioid Use Disorder (MOUD)","Improving Opioid Use Disorder Treatment Engagement Using Mobile Mindfulness in Childhood Trauma Survivors","ENROLLING_BY_INVITATION","2029-01","2026-06","2026-06-08","2025-07-29","Amy Meadows","OTHER",true,"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:\n\n* Will people with opioid use disorder and childhood trauma use mobile mindfulness training?\n* Will mobile mindfulness training help people with opioid use disorder and childhood trauma have decreased markers of psychological stress?\n\nParticipants will:\n\nBe given access to mobile mindfulness training and encouragement to use it daily for 30 days.\n\nKeep 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.",null,[19],"Opioid Use Disorder",[21,22,23,24],"opioid use disorder","mindfulness","childhood trauma","treatment","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},60,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":40},"BEHAVIORAL","Mobile Mindfulness Training","Participants will be instructed to complete a mobile application-based mindfulness training daily for 30 days.",[38,39],"Mobile Mindfulness First","Treatment As Usual First",[41],"Headspace",[43,47],{"measure":44,"description":45,"timeFrame":46},"Feasibility of Access","Proportion of enrolled participants who access the online mobile mindfulness training (mMT) application at least once.","75 days after enrollment",{"measure":48,"description":49,"timeFrame":46},"Proportion of Acceptability","Proportion of enrolled active condition participants who report using the online mobile mindfulness training application at least 25 times in 30 days.",[51,55],{"measure":52,"description":53,"timeFrame":54},"Change in Trauma Symptoms","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.","180 days after enrollment",{"measure":56,"description":57,"timeFrame":54},"Change in Mindfulness","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.","ALL","18 Years","65 Years",false,{"inclusion":63,"exclusion":69,"raw_text":76},[64,65,66,67,68],"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\u002Fnaloxone, 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\u002For Childhood Trauma Questionnaire.",[70,71,72,73,74,75],"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)","Inclusion Criteria:\n\n* Clinically diagnosed with Opioid Use Disorder (per DSM5 criteria)\n* Currently enrolled in treatment for Opioid Use Disorder at a clinic affiliated with UKHealthCare or University of Kentucky\n* On a stable dose of buprenorphine, buprenorphine\u002Fnaloxone, or naloxone (i.e., at least 30 days post-induction and on a stable dose for 30 days)\n* Able to read and understand English\n* Have a history of childhood trauma as measured by the Adverse Childhood Experiences scale and\u002For Childhood Trauma Questionnaire.\n\nExclusion Criteria:\n\n* Currently taking a beta-blocker, calcium-channel blocker, antiarrhythmic, corticosteroid, or immune modulator medication\n* Uncontrolled acute or chronic health conditions (e.g., active infections, autoimmune conditions, cancer undergoing active treatment)\n* Current or expected pregnancy\n* Current mindfulness practice (i.e., participant reports practicing mindfulness for 10 minutes or more per week)\n* Primary psychotic illness\n* Diagnosis of a disorder known to interfere with neurocognitive function (e.g., estimated full scale IQ below 70 or diagnosis of dementia)",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"University of Kentucky","Lexington","Kentucky","40509","United States",{"lat":88,"lon":89},37.98869,-84.47772,[],[92],{"name":93,"affiliation":82,"role":94},"Amy Meadows, M.D.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":99},[19],[],{"nct_id":4,"found":61,"summary":17,"prompt_version":17}]