Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-09 @ 11:28 AM
Study NCT ID:
NCT06857968
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-01
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Mindfulness Training (mMT) for People in Medication Treatment of Opioid Use Disorder (MOUD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Heart Rate Variability', 'timeFrame': '180 days after enrollment', 'description': 'Change in high frequency heart rate variability between baseline and 180 days after enrollment.'}, {'measure': 'Change in inflammatory marker high-sensitivity C-reactive protein', 'timeFrame': '180 days after enrollment', 'description': 'Change in high sensitivity C-reactive protein (hsCRP) between baseline and 180 days after enrollment.'}, {'measure': 'Change in inflammatory marker interleukin-6', 'timeFrame': '180 days after enrollment', 'description': 'Change in interleukin-6 (IL6) between baseline and 180 days post-enrollment.'}], 'primaryOutcomes': [{'measure': 'Feasibility of Access', 'timeFrame': '75 days after enrollment', 'description': 'Proportion of enrolled participants who access the online mobile mindfulness training (mMT) application at least once.'}, {'measure': 'Proportion of Acceptability', 'timeFrame': '75 days after enrollment', 'description': 'Proportion of enrolled active condition participants who report using the online mobile mindfulness training application at least 25 times in 30 days.'}], 'secondaryOutcomes': [{'measure': 'Change in Trauma Symptoms', 'timeFrame': '180 days after enrollment', 'description': '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.'}, {'measure': 'Change in Mindfulness', 'timeFrame': '180 days after enrollment', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['opioid use disorder', 'mindfulness', 'childhood trauma', 'treatment'], 'conditions': ['Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/naloxone, 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/or 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)'}, 'identificationModule': {'nctId': 'NCT06857968', 'briefTitle': 'Mobile Mindfulness Training (mMT) for People in Medication Treatment of Opioid Use Disorder (MOUD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Improving Opioid Use Disorder Treatment Engagement Using Mobile Mindfulness in Childhood Trauma Survivors', 'orgStudyIdInfo': {'id': '97193'}, 'secondaryIdInfos': [{'id': 'K23DA054309', 'link': 'https://reporter.nih.gov/quickSearch/K23DA054309', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment As Usual First', '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', 'interventionNames': ['Behavioral: Mobile Mindfulness Training']}, {'type': 'EXPERIMENTAL', 'label': 'Mobile Mindfulness First', '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.', 'interventionNames': ['Behavioral: Mobile Mindfulness Training']}], 'interventions': [{'name': 'Mobile Mindfulness Training', 'type': 'BEHAVIORAL', 'otherNames': ['Headspace'], 'description': 'Participants will be instructed to complete a mobile application-based mindfulness training daily for 30 days.', 'armGroupLabels': ['Mobile Mindfulness First', 'Treatment As Usual First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Amy Meadows, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Beginning 1 year after publication with no end date', 'ipdSharing': 'YES', 'description': 'After the study period, all identifiers will be removed from data and specimen, but the de-identified dataset free of PHI specifiers will be uploaded to a data sharing service.', 'accessCriteria': 'Data will be available in a data sharing repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amy Meadows', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Amy Meadows', 'investigatorAffiliation': 'University of Kentucky'}}}}