Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-02 @ 1:00 PM
Study NCT ID:
NCT06032559
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2023-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2023-09-04', 'studyFirstSubmitQcDate': '2023-09-04', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of drug use', 'timeFrame': 'Baseline through 52 weeks', 'description': 'mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.'}], 'secondaryOutcomes': [{'measure': 'Chronic Pain', 'timeFrame': 'Baseline through 52 weeks', 'description': 'Chronic pain measured by the Brief Pain Inventory Short Form (range 0-10, with higher scores indicating worse pain).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use', 'Pain']}, 'descriptionModule': {'briefSummary': 'This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT). The investigators will also assess barriers and facilitators to integrating MORE into methadone treatment, and evaluate the impact of a sustainable train-the-trainer model on provider burden, intervention fidelity, intervention engagement, and outcomes. Participants will be assigned to a higher intensity MORE implementation strategy, a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training and feedback and no supervision, or methadone treatment as usual (TAU). We aim to:\n\n* Examine barriers and facilitators to the implementation of MORE and SMP in MT and evaluate strategies for optimizing training, fidelity, and engagement.\n* Evaluate the effectiveness and treatment fidelity of a higher intensity MORE implementation strategy versus a lower intensity, scripted mindfulness practice (SMP) implementation strategy as an adjunct to methadone TAU or methadone TAU, only. Outcomes include opioid and other drug use, craving, MT discontinuation, depression, anxiety, and physical pain (secondary outcomes) than patients randomized to TAU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking\n* age ≥18\n* currently on methadone\n* persistent or recurring pain that has lasted for a duration of 3 months of longer.\n\nExclusion Criteria:\n\n* severe cognitive impairment (score \\>23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)\n* suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)\n* inability to attend or fully participate in intervention sessions or assessments\n* previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies).'}, 'identificationModule': {'nctId': 'NCT06032559', 'acronym': 'IMPOWR-MORE', 'briefTitle': 'Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain', 'orgStudyIdInfo': {'id': 'Pro2022001626'}, 'secondaryIdInfos': [{'id': 'R01DA056537', 'link': 'https://reporter.nih.gov/quickSearch/R01DA056537', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MORE', 'description': 'Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU)', 'interventionNames': ['Behavioral: MORE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Scripted Mindfulness Practice (SMP)', 'description': 'Eight group sessions of scripted mindfulness practice plus TAU.', 'interventionNames': ['Behavioral: SMP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment-as-Usual', 'description': 'Methadone treatment as usual.', 'interventionNames': ['Other: TAU']}], 'interventions': [{'name': 'MORE', 'type': 'BEHAVIORAL', 'description': 'MORE plus TAU', 'armGroupLabels': ['MORE']}, {'name': 'SMP', 'type': 'BEHAVIORAL', 'description': 'SMP plus TAU', 'armGroupLabels': ['Scripted Mindfulness Practice (SMP)']}, {'name': 'TAU', 'type': 'OTHER', 'description': 'TAU only', 'armGroupLabels': ['Treatment-as-Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nina Cooperman', 'role': 'CONTACT', 'email': 'cooperna@rwjms.rutgers.edu', 'phone': '7322358569'}], 'facility': 'Rutgers Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '04108', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ericc Garland, PhD', 'role': 'CONTACT', 'email': 'Eric.Garland@socwk.utah.edu', 'phone': '(801) 581-3826'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Nina Cooperman, PsyD', 'role': 'CONTACT', 'email': 'cooperna@rwjms.rutgers.edu', 'phone': '732-235-8569'}, {'name': 'Eric Garland, PhD', 'role': 'CONTACT', 'email': 'eric.garland@socwk.utah.edu', 'phone': '801-581-3826'}], 'overallOfficials': [{'name': 'Eric Garland, Ph', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Robert Wood Johnson Medical School'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Beginning 3 months and ending five years after study publication.', 'ipdSharing': 'YES', 'description': 'All participant data collected during the trial will be shared after de-identification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'University of Utah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nina A. Cooperman, Psy. D.', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}